Halyard 13903Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 20680651139034), received between Apr 13, 2017 and Jul 9, 2020 — classified as 1 death, 14 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (28 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SEVEN DIFFERENT PATIENTS. THIS IS THE SEVENTH OF SEVEN REPORTS. REFER TO 3006646024-2020-00018 FOR THE FIRST REPORT, REFER TO 3006646024-2020-00019 FOR THE SECOND REPORT, REFER TO 3006646024-2020-00020 FOR THE THIRD REPORT, REFER TO 3006646024-2020-00021 FOR THE FOURTH REPORT, REFER TO 3006646024-2020-00022 FOR THE FIFTH REPORT, REFER TO 3006646024-2020-00023 FOR THE SIXTH REPORT. IT WAS REPORTED THAT A PATIENT DEVELOPED ANGIOEDEMA. NO FURTHER PATIENT OR EVENT SPECIFIC INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10255861 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SEVEN DIFFERENT PATIENTS. THIS IS THE SIXTH OF SEVEN REPORTS. REFER TO 3006646024-2020-00018 FOR THE FIRST REPORT, REFER TO 3006646024-2020-00019 FOR THE SECOND REPORT, REFER TO 3006646024-2020-00020 FOR THE THIRD REPORT, REFER TO 3006646024-2020-00021 FOR THE FOURTH REPORT, REFER TO 3006646024-2020-00022 FOR THE FIFTH REPORT, REFER TO 3006646024-2020-00024 FOR THE SEVENTH REPORT. IT WAS REPORTED THAT A PATIENT DEVELOPED ANGIOEDEMA. NO FURTHER PATIENT OR EVENT SPECIFIC INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10255852 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SEVEN DIFFERENT PATIENTS. THIS IS THE FOURTH OF SEVEN REPORTS. REFER TO 3006646024-2020-00018 FOR THE FIRST REPORT, REFER TO 3006646024-2020-00019 FOR THE SECOND REPORT, REFER TO 3006646024-2020-00020 FOR THE THIRD REPORT, REFER TO 3006646024-2020-00022 FOR THE FIFTH REPORT, REFER TO 3006646024-2020-00023 FOR THE SIXTH REPORT, REFER TO 3006646024-2020-00024 FOR THE SEVENTH REPORT. IT WAS REPORTED THAT A NEWLY INTUBATED PATIENT DEVELOPED SUDDEN ANGIOEDEMA FOLLOWING MOUTH CARE. THE PATIENT'S EYES WERE SWOLLEN SHUT, CHEEKS AND LIPS WERE SWOLLEN, AND "TONGUE IS OUT OF HER MOUTH." ADDITIONAL INFORMATION WAS RECEIVED 07-JUL-2020 IN USER FACILITY SUBMITTED MEDWATCH REPORT MW5095069. THE EVENT DESCRIPTION STATED, "USED AVANOS ORAL CARE 24 HOUR KIT (Q4 HOUR) 97014 ON 4 PATIENTS AND EACH DEVELOPED SWELLING OF THE LIPS, CHEEKS, AND TONGUE. FDA SAFETY REPORT ID# [NUMBER REDACTED]."

  Patient problems: No Code Available; Reaction; Swelling

  MAUDE report 10255343 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED 09-JUL-2020 INDICATED THE PATIENT WAS ADMITTED ON (B)(6) 2020. PATIENT WAS INTUBATED (B)(6) 2020 AND ORAL CARE KIT WAS USED SAME DAY. ON (B)(6) 2020 AT 0800 TONGUE SWELLING WAS DOCUMENTED. DECADRON WAS GIVEN FOR 2 DAYS EVERY 6 HOURS. ENT [EAR, NOSE, THROAT] CONSULTED ON (B)(6) 2020, NO INTERVENTION PERFORMED. ON (B)(6) 2020 THE PATIENT REQUIRED A TRACHEOSTOMY. PATIENT WAS DISCHARGED TO LTAC [LONG TERM ADULT CARE] ON (B)(6) 2020.

  Patient problems: Reaction; Swelling

  MAUDE report 10255332 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SEVEN DIFFERENT PATIENTS. THIS IS THE THIRD OF SEVEN REPORTS. REFER TO 3006646024-2020-00018 FOR THE FIRST REPORT. REFER TO 3006646024-2020-00019 FOR THE SECOND REPORT. REFER TO 3006646024-2020-00021 FOR THE FOURTH REPORT. REFER TO 3006646024-2020-00022 FOR THE FIFTH REPORT. REFER TO 3006646024-2020-00023 FOR THE SIXTH REPORT. REFER TO 3006646024-2020-00024 FOR THE SEVENTH REPORT. IT WAS REPORTED THAT A PATIENT HAD SUDDEN TONGUE AND LIP SWELLING. NO FURTHER PATIENT OR EVENT SPECIFIC INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED 07-JUL-2020 IN USER FACILITY SUBMITTED MEDWATCH REPORT MW5095069. THE EVENT DESCRIPTION STATED, "USED AVANOS ORAL CARE 24 HOUR KIT (Q4 HOUR) 97014 ON 4 PATIENTS AND EACH DEVELOPED SWELLING OF THE LIPS, CHEEKS, AND TONGUE. FDA SAFETY REPORT ID# "[NUMBER REDACTED]."

  Patient problems: Reaction; Swelling

  MAUDE report 10255329 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SEVEN DIFFERENT PATIENTS. THIS IS THE FIFTH OF SEVEN REPORTS. REFER TO 3006646024-2020-00018 FOR THE FIRST REPORT. REFER TO 3006646024-2020-00019 FOR THE SECOND REPORT . REFER TO 3006646024-2020-00020 FOR THE THIRD REPORT . REFER TO 3006646024-2020-00021 FOR THE FOURTH REPORT. REFER TO 3006646024-2020-00023 FOR THE SIXTH REPORT. REFER TO 3006646024-2020-00024 FOR THE SEVENTH REPORT. IT WAS REPORTED THAT A PATIENT DEVELOPED ANGIOEDEMA. NO FURTHER PATIENT OR EVENT SPECIFIC INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10255308 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SEVEN DIFFERENT PATIENTS. THIS IS THE FIRST OF SEVEN REPORTS. REFER TO 3006646024-2020-00019 FOR THE SECOND REPORT. REFER TO 3006646024-2020-00020 FOR THE THIRD REPORT. REFER TO 3006646024-2020-00021 FOR THE FOURTH REPORT. REFER TO 3006646024-2020-00022 FOR THE FIFTH REPORT. REFER TO 3006646024-2020-00023 FOR THE SIXTH REPORT. REFER TO 3006646024-2020-00024 FOR THE SEVENTH REPORT. IT WAS REPORTED THAT THE PATIENT'S TONGUE AND LIPS WERE SWOLLEN AND FACE AND EYES WERE "PUFFY." PATIENT WAS INTUBATED ON VENTILATOR "DAY 14 AND 15." USE OF THE MOUTH CARE KIT WAS DISCONTINUED. PHYSICIAN ADMINISTERED "3-4 TREATMENTS OF DECADRON." PATIENT EVENTUALLY WAS EXTUBATED, ON 2L NC [2 LITER NASAL CANNULA], AND HIS LIPS AND TONGUE RETURNED TO NORMAL. ADDITIONAL INFORMATION WAS RECEIVED 07-JUL-2020 IN USER FACILITY SUBMITTED MEDWATCH REPORT MW5095069. THE EVENT DESCRIPTION STATED, "USED AVANOS ORAL CARE 24 HOUR KIT (Q4 HOUR) 97014 ON 4 PATIENTS AND EACH DEVELOPED SWELLING OF THE LIPS, CHEEKS, AND TONGUE. FDA SAFETY REPORT ID# [NUMBER REDACTED]."

  Patient problems: Reaction; Swelling

  MAUDE report 10255303 ↗
• InjuryJun 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3006646024-2018-00023 FOR THE FIRST PATIENT. REFER TO 3006646024-2018-00024 FOR THE SECOND PATIENT. IT WAS REPORTED THAT SEVERAL PATIENTS EXPERIENCED A RESPONSE OF ANGIOEDEMA FOUR OR FIVE WEEKS AGO ASSOCIATED WITH THE USE OF THE MOUTH MOISTURIZER. IT WAS NOTED THAT THERE WAS NO WAY OF TRACING THE PATIENTS OR DETERMINING THEIR OUTCOME OR STATUS.

  Patient problems: No Code Available

  MAUDE report 7605670 ↗
• InjuryJun 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3006646024-2018-00023 FOR THE FIRST PATIENT. REFER TO 3006646024-2018-00025 FOR THE THIRD PATIENT. IT WAS REPORTED THAT SEVERAL PATIENTS EXPERIENCED A RESPONSE OF ANGIOEDEMA FOUR OR FIVE WEEKS AGO ASSOCIATED WITH THE USE OF THE MOUTH MOISTURIZER. IT WAS NOTED THAT THERE WAS NO WAY OF TRACING THE PATIENTS OR DETERMINING THEIR OUTCOME OR STATUS.

  Patient problems: No Code Available

  MAUDE report 7605608 ↗
• InjuryJun 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3006646024-2018-00024 FOR THE SECOND PATIENT. REFER TO 3006646024-2018-00025 FOR THE THIRD PATIENT. IT WAS REPORTED THAT SEVERAL PATIENTS EXPERIENCED A RESPONSE OF ANGIOEDEMA FOUR OR FIVE WEEKS AGO ASSOCIATED WITH THE USE OF THE MOUTH MOISTURIZER. IT WAS NOTED THAT THERE WAS NO WAY OF TRACING THE PATIENTS OR DETERMINING THEIR OUTCOME OR STATUS.

  Patient problems: No Code Available

  MAUDE report 7605406 ↗
• InjuryJun 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 3006646024-2018-00019 FOR THE FIRST EVENT. REFER TO 3006646024-2018-00020 FOR THE SECOND EVENT. REFER TO 3006646024-2018-00021 FOR THE THIRD EVENT. THE PATIENT EXPERIENCED TONGUE SWELLING AFTER USING THE ORAL CARE KIT. THE CLINICIANS STOPPED USING THE KIT. THE PATIENT RECEIVED STEROIDS. IT WAS REPORTED THE SWELLING WAS BETTER AFTER THE ORAL CARE KIT WAS NO LONGER USED. THE KITS WERE ONLY IDENTIFIED FOR COMMON TREATMENT ACROSS ALL THE AFFECTED PATIENTS IN WHICH THE SYMPTOMS WERE ATTRIBUTABLE.

  Patient problems: Swelling

  MAUDE report 7560850 ↗
• DeathJun 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 3006646024-2018-00019 FOR THE FIRST EVENT. REFER TO 3006646024-2018-00020 FOR THE SECOND EVENT. REFER TO 3006646024-2018-00022 FOR THE FOURTH EVENT. THE PATIENT EXPERIENCED TONGUE SWELLING AFTER USING THE ORAL CARE KIT. THE PATIENT DIED DUE HEALTH ISSUES. THE CLINICIANS REPORTED THE SWELLING COMPLICATION WERE UNCOMFORTABLE SYMPTOMS WHICH DID NOT MAKE THE PATIENT'S CONDITION BETTER, BUT THE PATIENT'S UNDERLYING AGE, AND COMORBIDITIES HAD MORE TO DO WITH THE PATIENT'S PASSING RATHER THAN THE TONGUE SWELLING. THE KITS WERE ONLY IDENTIFIED FOR COMMON TREATMENT ACROSS ALL THE AFFECTED PATIENTS IN WHICH THE SYMPTOMS WERE ATTRIBUTABLE.

  Patient problems: Death; Swelling

  MAUDE report 7560846 ↗
• InjuryJun 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 3006646024-2018-00019 FOR THE FIRST EVENT. REFER TO 3006646024-2018-00021 FOR THE THIRD EVENT. REFER TO 3006646024-2018-00022 FOR THE FOURTH EVENT. THE PATIENT EXPERIENCED LARYNGIOEDEMA AND STRIDOR AFTER USING THE ORAL CARE KIT. THE CLINICIANS STOPPED USING THE KIT. THE PATIENT RECEIVED STEROIDS. THE PATIENT WAS REINTUBATED 1-DAY LATER AND RECEIVED A TRACHEOSTOMY 1-WEEK LATER. IT WAS REPORTED THE SWELLING WAS BETTER AFTER THE ORAL CARE KIT WAS NO LONGER USED. THE KITS WERE ONLY IDENTIFIED FOR COMMON TREATMENT ACROSS ALL THE AFFECTED PATIENTS IN WHICH THE SYMPTOMS WERE ATTRIBUTABLE.

  Patient problems: Edema; No Code Available

  MAUDE report 7560840 ↗
• InjuryJun 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 3006646024-2018-00020 FOR THE SECOND EVENT. REFER TO 3006646024-2018-00021 FOR THE THIRD EVENT. REFER TO 3006646024-2018-00022 FOR THE FOURTH EVENT. THE PATIENT EXPERIENCED TONGUE SWELLING AFTER USING THE ORAL CARE KIT. THE CLINICIANS STOPPED USING THE KIT. IT WAS REPORTED THE SWELLING WAS BETTER AFTER THE ORAL CARE KIT WAS NO LONGER USED. THE KITS WERE ONLY IDENTIFIED FOR COMMON TREATMENT ACROSS ALL THE AFFECTED PATIENTS IN WHICH THE SYMPTOMS WERE ATTRIBUTABLE.

  Patient problems: No Code Available; Swelling

  MAUDE report 7560839 ↗
• MalfunctionNov 28, 2017Break; Break

  IT WAS REPORTED THAT A SWAB SPONGE ON THE END OF THE TOOTHETTES WERE COMING OFF THE SUCTION HANDLE IN THE PATIENT'S MOUTH. THE CLINICIAN SUCCESSFULLY RETRIEVED THE SWAB FROM THE PATIENT'S MOUTH. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7064136 ↗
• MalfunctionNov 6, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE REGISTERED NURSE THAT THE TOOTHBRUSH COMES APART. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7004999 ↗
• MalfunctionNov 3, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPONGE FELL OFF DURING ORAL CARE, AND THE PATIENT WAS NOT BITING DOWN. THE DEVICE WAS RETRIEVED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7000614 ↗
• MalfunctionOct 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED 10 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT PATIENTS. THIS IS THE TENTH OF TEN REPORTS. REFER TO 8030647-2017-00121 FOR THE FIRST PATIENT. REFER TO 8030647-2017-00122 FOR THE SECOND PATIENT. REFER TO 8030647-2017-00123 FOR THE THIRD PATIENT. REFER TO 8030647-2017-00124 FOR THE FOURTH PATIENT. REFER TO 8030647-2017-00125 FOR THE FIFTH PATIENT. REFER TO 8030647-2017-00126 FOR THE SIXTH PATIENT. REFER TO 8030647-2017-00127 FOR THE SEVENTH PATIENT. REFER TO 8030647-2017-00128 FOR THE EIGHTH PATIENT. REFER TO 8030647-2017-00129 FOR THE NINTH PATIENT. IT WAS REPORTED BY THE DISTRIBUTOR THAT REPORTS "DEAR VENDOR, PLEASE REVIEW AND PROVIDE A RESPONSE TO THE PRODUCT QUALITY ISSUE REPORTED. THE GREEN SPONGE BREAKS OFF WHEN USE AND HAS OCCURRED TEN TIMES. THERE WERE NO INJURIES REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON 02-AUG-2017 THAT STATES, THERE WAS NO SITUATION OF PATIENT HARM TO REPORT FOR ANY OF THE INCIDENTS CITED. THEREFORE, THE STAFF DID NOT RECORD ANY INFORMATION REGARDING THE PATIENT,AND NO MEDICAL INTERVENTION WAS PERFORMED IN ANY INCIDENT. THE ONLY "INTERVENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6982995 ↗
• MalfunctionOct 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED 10 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT PATIENTS. THIS IS THE NINTH OF TEN REPORTS. REFER TO 8030647-2017-00121 FOR THE FIRST PATIENT. REFER TO 8030647-2017-00122 FOR THE SECOND PATIENT. REFER TO 8030647-2017-00123 FOR THE THIRD PATIENT. REFER TO 8030647-2017-00124 FOR THE FOURTH PATIENT. REFER TO 8030647-2017-00125 FOR THE FIFTH PATIENT. REFER TO 8030647-2017-00126 FOR THE SIXTH PATIENT. REFER TO 8030647-2017-00127 FOR THE SEVENTH PATIENT. REFER TO 8030647-2017-00128 FOR THE EIGHTH PATIENT. REFER TO 8030647-2017-00130 FOR THE TENTH PATIENT. IT WAS REPORTED BY THE DISTRIBUTOR THAT REPORTS "DEAR VENDOR, PLEASE REVIEW AND PROVIDE A RESPONSE TO THE PRODUCT QUALITY ISSUE REPORTED. THE GREEN SPONGE BREAKS OFF WHEN USE AND HAS OCCURRED TEN TIMES. THERE WERE NO INJURIES REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON 02-AUG-2017 THAT STATES, THERE WAS NO SITUATION OF PATIENT HARM TO REPORT FOR ANY OF THE INCIDENTS CITED. THEREFORE, THE STAFF DID NOT RECORD ANY INFORMATION REGARDING THE PATIENT,AND NO MEDICAL INTERVENTION WAS PERFORMED IN ANY INCIDENT. THE ONLY "INTERVENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6982970 ↗
• MalfunctionOct 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED 10 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT PATIENTS. THIS IS THE EIGHTH OF TEN REPORTS. REFER TO 8030647-2017-00121 FOR THE FIRST PATIENT, REFER TO 8030647-2017-00122 FOR THE SECOND PATIENT, REFER TO 8030647-2017-00123 FOR THE THIRD PATIENT, REFER TO 8030647-2017-00124 FOR THE FOURTH PATIENT, REFER TO 8030647-2017-00125 FOR THE FIFTH PATIENT, REFER TO 8030647-2017-00126 FOR THE SIXTH PATIENT, REFER TO 8030647-2017-00127 FOR THE SEVENTH PATIENT, REFER TO 8030647-2017-00129 FOR THE NINTH PATIENT, REFER TO 8030647-2017-00130 FOR THE TENTH PATIENT. IT WAS REPORTED BY THE DISTRIBUTOR THAT REPORTS "DEAR VENDOR, PLEASE REVIEW AND PROVIDE A RESPONSE TO THE PRODUCT QUALITY ISSUE REPORTED. THE GREEN SPONGE BREAKS OFF WHEN USE AND HAS OCCURRED TEN TIMES. THERE WERE NO INJURIES REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON 02-AUG-2017 THAT STATES, THERE WAS NO SITUATION OF PATIENT HARM TO REPORT FOR ANY OF THE INCIDENTS CITED. THEREFORE, THE STAFF DID NOT RECORD ANY INFORMATION REGARDING THE PATIENT,AND NO MEDICAL INTERVENTION WAS PERFORMED IN ANY INCIDENT. THE ONLY "INTERVENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6982942 ↗
• MalfunctionOct 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED 10 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT PATIENTS. THIS IS THE SIXTH OF TEN REPORTS. REFER TO 8030647-2017-00121 FOR THE FIRST PATIENT. REFER TO 8030647-2017-00122 FOR THE SECOND PATIENT. REFER TO 8030647-2017-00123 FOR THE THIRD PATIENT. REFER TO 8030647-2017-00124 FOR THE FOURTH PATIENT. REFER TO 8030647-2017-00125 FOR THE FIFTH PATIENT. REFER TO 8030647-2017-00127 FOR THE SEVENTH PATIENT. REFER TO 8030647-2017-00128 FOR THE EIGHTH PATIENT. REFER TO 8030647-2017-00129 FOR THE NINTH PATIENT. REFER TO 8030647-2017-00130 FOR THE TENTH PATIENT. IT WAS REPORTED BY THE DISTRIBUTOR THAT REPORTS "DEAR VENDOR, PLEASE REVIEW AND PROVIDE A RESPONSE TO THE PRODUCT QUALITY ISSUE REPORTED. THE GREEN SPONGE BREAKS OFF WHEN USE AND HAS OCCURRED TEN TIMES. THERE WERE NO INJURIES REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON 02-AUG-2017 THAT STATES, THERE WAS NO SITUATION OF PATIENT HARM TO REPORT FOR ANY OF THE INCIDENTS CITED. THEREFORE, THE STAFF DID NOT RECORD ANY INFORMATION REGARDING THE PATIENT,AND NO MEDICAL INTERVENTION WAS PERFORMED IN ANY INCIDENT. THE ONLY "INTERVENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6982937 ↗
• MalfunctionOct 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED 10 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT PATIENTS. THIS IS THE FIFTH OF TEN REPORTS. REFER TO 8030647-2017-00121 FOR THE FIRST PATIENT. REFER TO 8030647-2017-00122 FOR THE SECOND PATIENT. REFER TO 8030647-2017-00123 FOR THE THIRD PATIENT. REFER TO 8030647-2017-00124 FOR THE FOURTH PATIENT. REFER TO 8030647-2017-00126 FOR THE SIXTH PATIENT. REFER TO 8030647-2017-00127 FOR THE SEVENTH PATIENT. REFER TO 8030647-2017-00128 FOR THE EIGHTH PATIENT. REFER TO 8030647-2017-00129 FOR THE NINTH PATIENT. REFER TO 8030647-2017-00130 FOR THE TENTH PATIENT. IT WAS REPORTED BY THE DISTRIBUTOR THAT REPORTS "DEAR VENDOR, PLEASE REVIEW AND PROVIDE A RESPONSE TO THE PRODUCT QUALITY ISSUE REPORTED. THE GREEN SPONGE BREAKS OFF WHEN USE AND HAS OCCURRED TEN TIMES. THERE WERE NO INJURIES REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON 02-AUG-2017 THAT STATES, THERE WAS NO SITUATION OF PATIENT HARM TO REPORT FOR ANY OF THE INCIDENTS CITED. THEREFORE, THE STAFF DID NOT RECORD ANY INFORMATION REGARDING THE PATIENT,AND NO MEDICAL INTERVENTION WAS PERFORMED IN ANY INCIDENT. THE ONLY "INTERVENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6982936 ↗
• MalfunctionOct 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED 10 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT PATIENTS. THIS IS THE SEVENTH OF TEN REPORTS. REFER TO 8030647-2017-00121 FOR THE FIRST PATIENT. REFER TO 8030647-2017-00122 FOR THE SECOND PATIENT. REFER TO 8030647-2017-00123 FOR THE THIRD PATIENT. REFER TO 8030647-2017-00124 FOR THE FOURTH PATIENT. REFER TO 8030647-2017-00125 FOR THE FIFTH PATIENT. REFER TO 8030647-2017-00126 FOR THE SIXTH PATIENT. REFER TO 8030647-2017-00128 FOR THE EIGHTH PATIENT. REFER TO 8030647-2017-00129 FOR THE NINTH PATIENT. REFER TO 8030647-2017-00130 FOR THE TENTH PATIENT. IT WAS REPORTED BY THE DISTRIBUTOR THAT REPORTS "DEAR VENDOR, PLEASE REVIEW AND PROVIDE A RESPONSE TO THE PRODUCT QUALITY ISSUE REPORTED. THE GREEN SPONGE BREAKS OFF WHEN USE AND HAS OCCURRED TEN TIMES. THERE WERE NO INJURIES REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON 02-AUG-2017 THAT STATES, THERE WAS NO SITUATION OF PATIENT HARM TO REPORT FOR ANY OF THE INCIDENTS CITED. THEREFORE, THE STAFF DID NOT RECORD ANY INFORMATION REGARDING THE PATIENT,AND NO MEDICAL INTERVENTION WAS PERFORMED IN ANY INCIDENT. THE ONLY "INTERVENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6982935 ↗
• MalfunctionOct 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED 10 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT PATIENTS. THIS IS THE THIRD OF TEN REPORTS. REFER TO 8030647-2017-00121 FOR THE FIRST PATIENT. REFER TO 8030647-2017-00122 FOR THE SECOND PATIENT. REFER TO 8030647-2017-00124 FOR THE FOURTH PATIENT. REFER TO 8030647-2017-00125 FOR THE FIFTH PATIENT. REFER TO 8030647-2017-00126 FOR THE SIXTH PATIENT. REFER TO 8030647-2017-00127 FOR THE SEVENTH PATIENT. REFER TO 8030647-2017-00128 FOR THE EIGHTH PATIENT. REFER TO 8030647-2017-00129 FOR THE NINTH PATIENT. REFER TO 8030647-2017-00130 FOR THE TENTH PATIENT. IT WAS REPORTED BY THE DISTRIBUTOR THAT REPORTS "DEAR VENDOR, PLEASE REVIEW AND PROVIDE A RESPONSE TO THE PRODUCT QUALITY ISSUE REPORTED. THE GREEN SPONGE BREAKS OFF WHEN USE AND HAS OCCURRED TEN TIMES. THERE WERE NO INJURIES REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON 02-AUG-2017 THAT STATES, THERE WAS NO SITUATION OF PATIENT HARM TO REPORT FOR ANY OF THE INCIDENTS CITED. THEREFORE, THE STAFF DID NOT RECORD ANY INFORMATION REGARDING THE PATIENT,AND NO MEDICAL INTERVENTION WAS PERFORMED IN ANY INCIDENT. THE ONLY "INTERVENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6982928 ↗
• MalfunctionOct 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED 10 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT PATIENTS. THIS IS THE FOURTH OF TEN REPORTS. REFER TO 8030647-2017-00121 FOR THE FIRST PATIENT. REFER TO 8030647-2017-00122 FOR THE SECOND PATIENT . REFER TO 8030647-2017-00123 FOR THE THIRD PATIENT. REFER TO 8030647-2017-00125 FOR THE FIFTH PATIENT. REFER TO 8030647-2017-00126 FOR THE SIXTH PATIENT. REFER TO 8030647-2017-00127 FOR THE SEVENTH PATIENT. REFER TO 8030647-2017-00128 FOR THE EIGHTH PATIENT. REFER TO 8030647-2017-00129 FOR THE NINTH PATIENT. REFER TO 8030647-2017-00130 FOR THE TENTH PATIENT. IT WAS REPORTED BY THE DISTRIBUTOR THAT REPORTS "DEAR VENDOR, PLEASE REVIEW AND PROVIDE A RESPONSE TO THE PRODUCT QUALITY ISSUE REPORTED. THE GREEN SPONGE BREAKS OFF WHEN USE AND HAS OCCURRED TEN TIMES. THERE WERE NO INJURIES REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON (B)(6) 2017 THAT STATES, THERE WAS NO SITUATION OF PATIENT HARM TO REPORT FOR ANY OF THE INCIDENTS CITED. THEREFORE, THE STAFF DID NOT RECORD ANY INFORMATION REGARDING THE PATIENT,AND NO MEDICAL INTERVENTION WAS PERFORMED IN ANY INCIDENT. THE ONLY "INTERVEN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6982924 ↗