Halyard 98701Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10680651987010), received between Aug 18, 2017 and Mar 24, 2023 — classified as 1 death, 3 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Break” (36 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2023Break; Break

  IT WAS REPORTED " ONE T-BAR MIGRATED TO FAT ZONE BETWEEN GASTRIC MUCOSA AND ABDOMINAL WALL. THOUGH THE T-BAR CAME OUT INTO STOMACH PROPERLY ONCE, THE T-BAR ENTERED INTO NEEDLE'S HOLE BY CHANCE. WHEN THE NEEDLE WAS PULLED, THE T-BAR MIGRATED. THE PATIENT HAS BRAIN DISORDER, AND IT IS DIFFICULT TO PERFORM A MEDICAL INTERVENTION. CURRENTLY THIS CASE GOT A FOLLOW-UP EXAMINATION FOR PAIN AND THE AFFECTED PART. AFTER THIS EVENT, GASTROSTOMY OPERATION WAS PERFORMED AGAIN. IT IS NOT SURE HOW ADMINISTERING NUTRITION TO THE PATIENT NOW." ADDITIONAL INFORMATION RECEIVED 03-MAR-2023 STATED "THE PATIENT INFORMATION IS STILL UNKNOWN, ONLY INFO AS ADULT. SINCE THE [PATIENT] HAS BRAIN DISORDER, IT'S DIFFICULT TO JUDGE WHETHER THE [PATIENT] FEELS PAIN DUE TO THE T-BAR MIGRATION, BUT SO FAR [PATIENT] CONDITION IS SAME, AND NO MEDICAL INTERVENTION HAS BEEN TAKEN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16611011 ↗
• MalfunctionFeb 21, 2023Break; Break

  IT WAS REPORTED "AFTER FIXING ANCHORS ON GASTRIC PARIETAL, SUTURES SNAPPED." THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16415095 ↗
• MalfunctionDec 21, 2022Break; Break

  IT WAS REPORTED, AFTER FIXING 3 T-BARS, ALL [THE] SUTURES SNAPPED AT THE SAME TIME WHEN A TUBE WAS INSERTED. THE PATIENT¿S STOMACH WENT DOWN, AND AIR WENT INTO THE ABDOMINAL CAVITY; THE PATIENT'S STOMA WAS CLOSED WITH A CLIP, HOSPITALIZATION WAS EXTENDED BY 2-WEEKS AND ANTIBIOTICS WERE ADMINISTERED. ALL T-BARS FELL DOWN IN THE STOMACH, NO ADDITIONAL MEDICAL ATTENTION REQUIRED. IT WAS ALSO REPORTED THAT THE PHYSICIAN PULLED THE SUTURES AND THERE WAS TOO MUCH TENSION. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16024041 ↗
• MalfunctionMar 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT ONE OF THE SUTURE THREADS SNAPPED AFTER ONE DAY OF USE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13732114 ↗
• MalfunctionMar 3, 2022Fracture; Fracture

  IT WAS REPORTED THAT AFTER A 12FR MIC-KEY GASTROSTOMY (G) TUBE WAS PLACED THREE WEEKS AGO IN THE PATIENT, IT WAS TO BE REPLACED WITH A 20FR G TUBE WITH THE USE OF A DILATOR. DURING THIS REPLACEMENT, THE T FASTENERS AROUND THE STOMA SNAPPED, AND THE NEW TUBE COULD NOT BE PLACED. THE 12FR TUBE WAS PUT BACK IN PLACE AND THREE NEW ANCHOR SUTURES WERE PLACED. A NEW G TUBE WILL BE PLACED SOON. NO INJURY TO PATIENT. PER ADDITIONAL INFORMATION RECEIVED ON 25 FEB 2022, A NEW G TUBE WAS PLACED WITHOUT PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13663877 ↗
• MalfunctionFeb 2, 2022Break; Break

  IT WAS REPORTED ENTERAL FEEDING DEVICE WAS PLACED IN THE STOMACH UNDER FLUOROSCOPY AND 3 ANCHORS WERE FIXED WITH GASTROPEXY. ONE "THREAD" SNAPPED DURING SURGERY, SO ANOTHER ONE WAS ADDED. FLUOROSCOPY WAS PERFORMED AND IT WAS CONFIRMED THAT THE T-BARS WERE ON THE WALL OF STOMACH WITH NO PROBLEM. AFTER 2 DAYS, IT WAS FOUND THAT 3 ANCHORS SNAPPED. FLUOROSCOPY WAS PERFORMED AND IT WAS CONFIRMED THAT THE T-BARS WERE ON THE WALL OF STOMACH WITH NO PROBLEM. ADDITIONAL INFORMATION RECEIVED (B)(6) 2022 STATED A GASTROSTOMY TUBE WAS PLACED BUT THE PLACEMENT WAS NOT DUE TO THE SUTURE BREAK. THE DRAIN TUBE HAD BEEN PLACED FOR ANOTHER REASON WHICH WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13430143 ↗
• InjuryMay 5, 2021Break; Break

  IT WAS REPORTED THAT TWO OF THE GASTROPEXY ANCHORS CAME OFF AND THE PATIENT DEVELOPED PERITONITIS. THE DEVICE WAS USED UNDER FLUOROSCOPY FOR GASTROSTOMY IN THE DEPARTMENT OF RADIOLOGY. THE WALL OF THE STOMACH WAS FIXED WITH GASTROPEXY, WIDENED WITH DILATOR AND A COMPETITOR'S GASTROSTOMY TUBE WAS PLACED IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED 15-APR-2021 INDICATED THE EXACT EVENT DATE IS UNKNOWN, BUT IT WAS ONE DAY AFTER IMPLANT. IT WAS NOT CLEAR IF THE SUTURES BROKE INSIDE OR OUTSIDE OF THE PATIENT. BOTH THE DILATOR AND THE GASTROSTOMY TUBE WERE COMPETITOR DEVICES. ACCORDING TO THE PHYSICIAN, THE POSITION OF THE STOMACH AND RIBS OVERLAPPED FOR THIS PATIENT. ADDITIONAL TREATMENT FOR THE PERITONITIS IS UNKNOWN, BUT THE PHYSICIAN MENTIONED THE PATIENT IS NOW "UNDER RECOVERY STEP."

  Patient problems: Peritonitis

  MAUDE report 11778028 ↗
• MalfunctionMay 29, 2020Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2020-00089 FOR THE FIRST EVENT. REFER TO 9611594-2020-00090 FOR THE SECOND EVENT. IT WAS REPORTED THERE WAS AN INCIDENT OF SUTURES BREAKING ON T-FASTENERS WHEN THE USER ATTEMPTED TO DILATE THE "TRACT." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED FROM THE USER STATED, "WE ENDED UP PLACING THE G-TUBE [GASTROSTOMY TUBE] IN THE PATIENT WITHOUT INCIDENT. THE PATIENT IS DOING FINE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10102577 ↗
• MalfunctionNov 2, 2019Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2019-00199 FOR THE SECOND EVENT. REFER TO 9611594-2019-00207 FOR THE THIRD EVENT. IT WAS REPORTED SEVERAL "T-FASTENERS HAVE BROKEN DURING USE AND SEVERAL IMMEDIATELY AFTER USE, SOME WITHIN 24 HOURS." THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9269859 ↗
• MalfunctionNov 2, 2019Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2019-00198 FOR THE FIRST EVENT. REFER TO 9611594-2019-00199 FOR THE SECOND EVENT. IT WAS REPORTED SEVERAL "T-FASTENERS HAVE BROKEN DURING USE AND SEVERAL IMMEDIATELY AFTER USE, SOME WITHIN 24 HOURS." THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9269846 ↗
• MalfunctionOct 31, 2019Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2019-00198 FOR THE FIRST EVENT. REFER TO 9611594-2019-00207 FOR THE THIRD EVENT. IT WAS REPORTED SEVERAL "T-FASTENERS HAVE BROKEN DURING USE AND SEVERAL IMMEDIATELY AFTER USE, SOME WITHIN 24 HOURS." THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9261866 ↗
• MalfunctionOct 16, 2019Break; Break

  IT WAS REPORTED THE SUTURE BROKE UPON INITIAL PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9197238 ↗
• MalfunctionJun 10, 2019Break; Break

  IT WAS REPORTED THAT "T-FASTENERS BROKE DURING DILATION OF A PATIENT'S STOMA TO PLACE A ENTERAL FEEDING TUBE." NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 23-MAY-2019 INDICATED "THE SUTURE BROKE WHEN THE DOCTOR TRIED TO CLIP THE BUTTON DOWN ON EVERY SINGLE ONE. SO THIS LEFT NO ANCHORS IN THE PATIENT AT THE END OF THE PROCEDURE. WE ALWAYS PLACE THE ANCHORS, THEN GET ACCESS WITH G-TUBE [GASTROSTOMY TUBE], AND THEN TIGHTEN THE ANCHORS DOWN WITH THE BUTTON AT THE VERY END."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8684385 ↗
• MalfunctionMar 22, 2019Break; Break

  IT WAS REPORTED THE SUTURE BROKE DURING USE. THE PROCEDURE WAS COMPLETED WITH A NEW ANCHOR. THERE WAS NO REPORTED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8443733 ↗
• MalfunctionMar 7, 2019Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2019-00038 FOR THE FIRST EVENT. IT WAS REPORTED THE SUTURES BROKE AND THE PATIENT HAD TO RETURN TO THE OPERATING ROOM (OR). ADDITIONALLY, THE T-FASTENER SUTURES HAVE NOT LASTED MORE THAN 48-HOURS BEFORE BREAKING. THERE WAS NO REPORTED INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8400584 ↗
• MalfunctionMar 7, 2019Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2019-00039 FOR THE SECOND EVENT. IT WAS REPORTED THE SUTURES BROKE AND THE PATIENT HAD TO RETURN TO THE OPERATING ROOM (OR). ADDITIONALLY, THE T-FASTENER SUTURES HAVE NOT LASTED MORE THAN 48-HOURS BEFORE BREAKING. THERE WAS NO REPORTED INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8400575 ↗
• MalfunctionFeb 10, 2019Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE FIFTH OF FIVE REPORTS. REFER TO 9611594-2019-00019 FOR THE FIRST PATIENT. REFER TO 9611594-2019-00020 FOR THE SECOND PATIENT. REFER TO 9611594-2019-00021 FOR THE THIRD PATIENT. REFER TO 9611594-2019-00022 FOR THE FOURTH PATIENT. IT WAS REPORTED THAT OVER THE PAST TWO MONTHS, TWO DIFFERENT SURGEONS HAVE EXPERIENCED SUTURES BREAK DURING LAPAROSCOPY PLACEMENT OF FEEDING TUBES. THE PHYSICIANS STATED THAT IF THE SUTURES WERE STRONGER, THEY WOULD NOT BREAK AS EASILY AS THEY HAVE. IT WAS NOTED THAT THE SUTURES BREAK "WHEN THEY'RE TRYING TO PULL THE GI UP TO THE FASCIA". THERE WAS NO PATIENT INJURY, BUT THE HOSPITAL STAYS WERE LENGTHENED FOR A PATIENT WHO HAD ABDOMINAL SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8324766 ↗
• MalfunctionFeb 10, 2019Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE FOURTH OF FIVE REPORTS. REFER TO 9611594-2019-00019 FOR THE FIRST PATIENT. REFER TO 9611594-2019-00020 FOR THE SECOND PATIENT. REFER TO 9611594-2019-00021 FOR THE THIRD PATIENT. REFER TO 9611594-2019-00023 FOR THE FIFTH PATIENT. IT WAS REPORTED THAT OVER THE PAST TWO MONTHS, TWO DIFFERENT SURGEONS HAVE EXPERIENCED SUTURES BREAK DURING LAPAROSCOPY PLACEMENT OF FEEDING TUBES. THE PHYSICIANS STATED THAT IF THE SUTURES WERE STRONGER, THEY WOULD NOT BREAK AS EASILY AS THEY HAVE. IT WAS NOTED THAT THE SUTURES BREAK "WHEN THEY'RE TRYING TO PULL THE GI UP TO THE FASCIA". THERE WAS NO PATIENT INJURY, BUT THE HOSPITAL STAYS WERE LENGTHENED FOR A PATIENT WHO HAD ABDOMINAL SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8324765 ↗
• MalfunctionFeb 10, 2019Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE SECOND OF FIVE REPORTS. REFER TO 9611594-2019-00019 FOR THE FIRST PATIENT. REFER TO 9611594-2019-00021 FOR THE THIRD PATIENT. REFER TO 9611594-2019-00022 FOR THE FOURTH PATIENT. REFER TO 9611594-2019-00023 FOR THE FIFTH PATIENT. IT WAS REPORTED THAT OVER THE PAST TWO MONTHS, TWO DIFFERENT SURGEONS HAVE EXPERIENCED SUTURES BREAK DURING LAPAROSCOPY PLACEMENT OF FEEDING TUBES. THE PHYSICIANS STATED THAT IF THE SUTURES WERE STRONGER, THEY WOULD NOT BREAK AS EASILY AS THEY HAVE. IT WAS NOTED THAT THE SUTURES BREAK "WHEN THEY'RE TRYING TO PULL THE GI UP TO THE FASCIA". THERE WAS NO PATIENT INJURY, BUT THE HOSPITAL STAYS WERE LENGTHENED FOR A PATIENT WHO HAD ABDOMINAL SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8324763 ↗
• MalfunctionFeb 10, 2019Break; Break

  (B)(6) MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE THIRD OF FIVE REPORTS. REFER TO 9611594-2019-00019 FOR THE FIRST PATIENT. REFER TO 9611594-2019-00020 FOR THE SECOND PATIENT. REFER TO 9611594-2019-00022 FOR THE FOURTH PATIENT. REFER TO 9611594-2019-00023 FOR THE FIFTH PATIENT. IT WAS REPORTED THAT OVER THE PAST TWO MONTHS, TWO DIFFERENT SURGEONS HAVE EXPERIENCED SUTURES BREAK DURING LAPAROSCOPY PLACEMENT OF FEEDING TUBES. THE PHYSICIANS STATED THAT IF THE SUTURES WERE STRONGER, THEY WOULD NOT BREAK AS EASILY AS THEY HAVE. IT WAS NOTED THAT THE SUTURES BREAK "WHEN THEY'RE TRYING TO PULL THE GI UP TO THE FASCIA". THERE WAS NO PATIENT INJURY, BUT THE HOSPITAL STAYS WERE LENGTHENED FOR A PATIENT WHO HAD ABDOMINAL SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8324761 ↗
• MalfunctionFeb 10, 2019Break; Break

  (B)(6) MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE FIRST OF FIVE REPORTS. REFER TO 9611594-2019-00020 FOR THE SECOND PATIENT. REFER TO 9611594-2019-00021 FOR THE THIRD PATIENT. REFER TO 9611594-2019-00022 FOR THE FOURTH PATIENT. REFER TO 9611594-2019-00023 FOR THE FIFTH PATIENT. IT WAS REPORTED THAT OVER THE PAST TWO MONTHS, TWO DIFFERENT SURGEONS HAVE EXPERIENCED SUTURES BREAK DURING LAPAROSCOPY PLACEMENT OF FEEDING TUBES. THE PHYSICIANS STATED THAT IF THE SUTURES WERE STRONGER, THEY WOULD NOT BREAK AS EASILY AS THEY HAVE. IT WAS NOTED THAT THE SUTURES BREAK "WHEN THEY'RE TRYING TO PULL THE GI UP TO THE FASCIA". THERE WAS NO PATIENT INJURY, BUT THE HOSPITAL STAYS WERE LENGTHENED FOR A PATIENT WHO HAD ABDOMINAL SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8324758 ↗
• MalfunctionFeb 8, 2019Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING A SINGLE PATIENT. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 9611594-2019-00015 FOR THE FIRST PATIENT. REFER TO 9611594-2019-00016 FOR THE SECOND PATIENT. REFER TO 9611594-2019-00017 FOR THE THIRD PATIENT. IT WAS REPORTED THAT OVER THE PAST TWO MONTHS, TWO DIFFERENT SURGEONS HAVE EXPERIENCED SUTURES BREAK DURING LAPAROSCOPY PLACEMENT OF FEEDING TUBES. THE PHYSICIANS STATED THAT IF THE SUTURES WERE STRONGER, THEY WOULD NOT BREAK AS EASILY AS THEY HAVE. ONE OF THE PHYSICIANS OPENED A KIT OF THREE SUTURES FOUR TIMES, AND "GAVE UP AND OPENED UP THE PATIENT AND PUT THE TUBE IN THAT WAY." NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8319681 ↗
• MalfunctionFeb 8, 2019Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING A SINGLE PATIENT. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 9611594-2019-00015 FOR THE FIRST PATIENT. REFER TO 9611594-2019-00016 FOR THE SECOND PATIENT. REFER TO 9611594-2019-00018 FOR THE FOURTH PATIENT. IT WAS REPORTED THAT OVER THE PAST TWO MONTHS, TWO DIFFERENT SURGEONS HAVE EXPERIENCED SUTURES BREAK DURING LAPAROSCOPY PLACEMENT OF FEEDING TUBES. THE PHYSICIANS STATED THAT IF THE SUTURES WERE STRONGER, THEY WOULD NOT BREAK AS EASILY AS THEY HAVE. ONE OF THE PHYSICIANS OPENED A KIT OF THREE SUTURES FOUR TIMES, AND "GAVE UP AND OPENED UP THE PATIENT AND PUT THE TUBE IN THAT WAY." NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8319678 ↗
• MalfunctionFeb 8, 2019Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING A SINGLE PATIENT. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 9611594-2019-00015 FOR THE FIRST PATIENT. REFER TO 9611594-2019-00017 FOR THE THIRD PATIENT. REFER TO 9611594-2019-00018 FOR THE FOURTH PATIENT. IT WAS REPORTED THAT OVER THE PAST TWO MONTHS, TWO DIFFERENT SURGEONS HAVE EXPERIENCED SUTURES BREAK DURING LAPAROSCOPY PLACEMENT OF FEEDING TUBES. THE PHYSICIANS STATED THAT IF THE SUTURES WERE STRONGER, THEY WOULD NOT BREAK AS EASILY AS THEY HAVE. ONE OF THE PHYSICIANS OPENED A KIT OF THREE SUTURES FOUR TIMES, AND "GAVE UP AND OPENED UP THE PATIENT AND PUT THE TUBE IN THAT WAY." NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8319677 ↗
• MalfunctionFeb 8, 2019Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING A SINGLE PATIENT. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 9611594-2019-00016 FOR THE SECOND PATIENT. REFER TO 9611594-2019-00017 FOR THE THIRD PATIENT. REFER TO 9611594-2019-00018 FOR THE FOURTH PATIENT. IT WAS REPORTED THAT OVER THE PAST TWO MONTHS, TWO DIFFERENT SURGEONS HAVE EXPERIENCED SUTURES BREAK DURING LAPAROSCOPY PLACEMENT OF FEEDING TUBES. THE PHYSICIANS STATED THAT IF THE SUTURES WERE STRONGER, THEY WOULD NOT BREAK AS EASILY AS THEY HAVE. ONE OF THE PHYSICIANS OPENED A KIT OF THREE SUTURES FOUR TIMES, AND "GAVE UP AND OPENED UP THE PATIENT AND PUT THE TUBE IN THAT WAY." NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8319674 ↗