Halyard 13535Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10680651135350), received between Mar 30, 2017 and Aug 13, 2019 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2019Break; Break

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. FDA MEDWATCH / FDA USER FACILITY REPORT # MW5087955 RECEIVED ON 22-JUL-2019, AND THE FOLLOWING INFORMATION WAS PROVIDED: "ONQ PUMP CATHETER BROKE OFF WHILE BEING REMOVED." NO INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8887362 ↗
• MalfunctionMay 22, 2019Break; Break

  ADDITIONAL INFORMATION RECEIVED (B)(6) 2019 INDICATED THE CATHETER WAS SECURED ON THE PATIENT WITH STERI STRIPS AND A TEGADERM. THE CATHETER WAS INSERTED THROUGH A STEEL NEEDLE AND IT WAS CONNECTED TO AN ON-Q ON DEMAND INFUSION PUMP. THE PATIENT EXPERIENCED DISCOMFORT DURING THE CATHETER REMOVAL. THE CATHETER WAS CATCHING AT THE END WHEN THE PHYSICIAN WAS REMOVING IT. THERE WAS A GREAT DEAL OF RESISTANCE SO A WARM COMPRESS WAS USED TO RELAX THE MUSCLES AND REMOVAL WAS ATTEMPTED AGAIN CAUSING THE PATIENT SOME DISCOMFORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8634666 ↗
• MalfunctionMay 17, 2019Break; Break

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THE CATHETER BROKE AT THE CONNECTION WHERE THE CLEAR SLEEVE CONNECTS. THE PATIENT WAS UNHARMED AND THE CLINICIANS WERE ABLE TO REMOVE THE REMAINING PORTION OF THE CATHETER. THE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8621255 ↗
• MalfunctionMay 10, 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 2026095-2019-00084 FOR THE FIRST EVENT. IT WAS REPORTED THAT THE CATHETER BROKE OFF INSIDE THE PATIENT. THE CATHETER, WHICH WAS PLACED IN THE INCISION FOR A TOTAL KNEE PROCEDURE, HAD BROKEN PROXIMALLY. THE EVENT OCCURRED WHEN THE PATIENT WAS IN THE HOSPITAL. THE CATHETER WAS STILL STICKING OUT FROM THE SURFACE OF THE SKIN, THE PATIENT WAS ABLE TO GRASP AND REMOVE THE REMAINDER OF THE CATHETER WITHOUT FURTHER INCIDENT. NO RESISTANCE WAS MET ACCORDING TO THE PHYSICIAN, AS THE DEVICE WAS BEING PULLED AND REMOVED BY THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8601568 ↗
• MalfunctionMay 10, 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 2026095-2019-00085 FOR THE SECOND EVENT. IT WAS REPORTED THAT THE CATHETER BROKE OFF INSIDE THE PATIENT. THE CATHETER, WHICH WAS PLACED IN THE INCISION FOR A TOTAL KNEE PROCEDURE, HAD BROKEN PROXIMALLY. THE EVENT OCCURRED WHEN THE PATIENT WAS DISCHARGED AND AT HOME. THE CATHETER WAS STILL STICKING OUT FROM THE SURFACE OF THE SKIN, THE PATIENT WAS ABLE TO GRASP AND REMOVE THE REMAINDER OF THE CATHETER WITHOUT FURTHER INCIDENT. NO RESISTANCE WAS MET ACCORDING TO THE PHYSICIAN, AS THE DEVICE WAS BEING PULLED AND REMOVED BY THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8601565 ↗
• MalfunctionMay 8, 2019Break; Break

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2019-00082 FOR THE FIRST REPORT. IT WAS REPORTED ON 18-APR-2019 THAT "TWO CATHETERS BROKE. ONE IN THE HOSPITAL...BROKE AT CONNECTION WHERE CLEAR SLEEVE CONNECTS. NO ISSUE WITH ANY PART OF CATHETER LEFT IN...PATIENT. ENTIRE CATHETER WAS COMPLETELY REMOVED. NO INJURY WAS REPORTED." ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019 INDICATED THE PATIENT WAS IN THE HOSPITAL AND THE EVENT OCCURRED (B)(6) 2019. "BECAUSE SOME OF THE CATHETER WAS STILL STICKING OUT FROM THE SURFACE OF THE SKIN, [THE PATIENT WAS] ABLE TO GRASP AND REMOVE THE REMAINDER OF THE CATHETER WITHOUT FURTHER INCIDENT. NO RESISTANCE WAS MET ACCORDING TO THE PHYSICIAN."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8592828 ↗
• MalfunctionMay 8, 2019Break; Break

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2019-00083 FOR THE SECOND REPORT. IT WAS REPORTED ON 18-APR-2019 THAT "TWO CATHETERS BROKE...OTHER WITH PATIENT AT HOME...BROKE AT CONNECTION WHERE CLEAR SLEEVE CONNECTS. NO ISSUE WITH ANY PART OF CATHETER LEFT IN...PATIENT. ENTIRE CATHETER WAS COMPLETELY REMOVED. NO INJURY WAS REPORTED." ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019 INDICATED THAT THE PHYSICIAN WAS CONTACTED ON (B)(6) 2019 REGARDING THIS INCIDENT. "BECAUSE SOME OF THE CATHETER WAS STILL STICKING OUT FROM THE SURFACE OF THE SKIN, [THE PATIENT WAS] ABLE TO GRASP AND REMOVE THE REMAINDER OF THE CATHETER WITHOUT FURTHER INCIDENT. NO RESISTANCE WAS MET ACCORDING TO THE PHYSICIAN."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8592826 ↗
• MalfunctionApr 5, 2019Break; Break

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: ABDOMINOPLASTY, CATHPLACE: IN WOUND BEFORE CLOSING. IT WAS REPORTED TWO CATHETERS WERE USED AND REMOVAL WAS ATTEMPTED AFTER THE PUMPS WERE SUCCESSFULLY EMPTIED. THE RIGHT CATHETER WAS EASILY REMOVED; HOWEVER, THE PATIENT EXPERIENCED PAIN WHEN THE NURSE ATTEMPTED REMOVING THE LEFT CATHETER. THE PATIENT WAS GIVEN PAIN RELIEF AND REMOVAL WAS ATTEMPTED AFTER AN HOUR. THE PATIENT STILL EXPERIENCED PAIN AND THE PHYSICIAN WAS NOTIFIED. WHEN THE PHYSICIAN ATTEMPTED REMOVING THE CATHETER IT SNAPPED WITH A SEGMENT OF ABOUT 10CM REMAINING INSIDE THE PATIENT. THE SURGEON WAS PLANNING TO LEAVE THE BROKEN SEGMENT IN-SITU. THE NURSES REPORTED THE CATHETER FELT TIGHT AND RESISTANCE WAS NOTED DURING REMOVAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 8489645 ↗
• MalfunctionFeb 22, 2019Break; Break

  FILL VOLUME: 125 ML, FLOW RATE: UNKNOWN, PROCEDURE: VERTICAL LAPAROTOMY, CATHPLACE: RECTUS SHEATH. IT WAS REPORTED A SILVER SOAKER CATHETER SNAPPED WHEN THE CLINICIAN WAS TRYING TO REMOVE IT AFTER 3-DAYS IN USE. INITIALLY, TWO CATHETERS WERE POSITIONED IN THE RECTUS SHEATH, ONE AT EACH SIDE, UNDER DIRECT VISION BY THE SURGEON AT THE END OF A VERTICAL LAPAROTOMY. AFTER 3-DAYS, WHEN IT WAS DECIDED THE CATHETERS SHOULD COME OUT, ONE OF THE CATHETERS WAS REMOVED EASILY, BUT THE OTHER ONE WAS STUCK. THE USUAL ADVISED REMEDIES WERE APPLIED (I,E. WARM PACKS, ETC.) BUT STILL IT WOULD NOT LOOSEN. WHILE PULLING, EVENTUALLY THE CATHETER BROKE LEAVING A 12CM SEGMENT OF THE SILVER-SOAKER CATHETER INSIDE THE PATIENT. THE PATIENT WAS NOT WELL DUE TO UNDERLYING HEALTH ISSUES, OTHER PATHOLOGIES AND HIGH ANAESTHETIC RISK. TAKING THE PATIENT BACK TO THE SURGICAL THEATRE TO HAVE ANOTHER LAPAROTOMY TO REMOVE THE CATHETER WAS JUDGED LESS THAN IDEAL. DURING DISCUSSIONS THE SURGEONS WERE CONTEMPLATING LEAVING THE BROKEN CATHETER SEGMENT INSIDE THE PATIENT'S BODY. ADDITIONAL INFORMATION RECEIVED 07-FEB-2019 STATED ACCORDING TO THE SURGEON IT WAS AN UNEVENTFUL PLACEMENT OF THE CATHETER, UNDER DIRECT VISION

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8361343 ↗
• InjuryJan 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: 500 ML, FLOW RATE: 8 ML/HR, PROCEDURE: ROBOTIC TOTAL LAPAROSCOPIC HYSTERECTOMY, CATHPLACE: MID ABDOMEN. IT WAS REPORTED THAT A DOCTOR HAD A PATIENT WHO EXPERIENCED AN INFECTION AFTER A ROBOTIC HYSTERECTOMY. ADDITIONAL INFORMATION RECEIVED ON 15-JAN-2019 STATED THAT PROCEDURE WAS ASSOCIATED WITH THE USE OF AN ON-Q CATHETER. THE LOCATION OF THE INFECTION WAS AT THE VAGINAL CUFF, AND WAS DIAGNOSED VIA PHYSICAL EXAM 10 DAYS AFTER THE PROCEDURE. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 8292419 ↗
• MalfunctionAug 20, 2018Break; Break

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: C-SECTION, CATHPLACE: UNKNOWN, DATE DEVICE PLACED: (B)(6) 2018, DATE DEVICE REMOVED: (B)(6) 2018. A REPORT WAS RECEIVED FROM THE USER FACILITY DIRECTLY VIA MAIL STATING THE REGISTERED NURSE (RN) ATTEMPTED TO REMOVE AN ON-Q PAIN BALL AND EXPERIENCED RESISTANCE. THE RN NOTIFIED THE RESIDENT DOCTOR. THE RESIDENT PULLED ON THE CATHETER TUBING AND REMOVED A MODERATE AMOUNT OF THE TUBING THEN THE TUBING BROKE. THE RESIDENT TOOK THE RN'S HEMOSTATS TO REMOVE THE REMAINING TUBING. WHILE THE RESIDENT WAS PULLING THE TUBING IT BROKE LEAVING THE REMAINING TUBING INSIDE THE PATIENT. THE RESIDENT NOTIFIED THE ATTENDING PHYSICIAN AND WAS INSTRUCTED "OK TO LEAVE INSIDE, IT'S STERILE AND THE BODY WILL ABSORB IT OR IT WILL REMAIN." THE RN APPLIED STERILE GAUZE DRESSING OVER THE PAIN BALL SITE WITH PAPER TAPE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7798985 ↗
• MalfunctionApr 4, 2018Break; Break

  IT WAS INITIALLY REPORTED THAT A SHEATH MIGHT HAVE GOTTEN CAUGHT INSIDE A PATIENT, BUT WAS ABLE TO BE REMOVED. ADDITIONAL INFORMATION RECEIVED ON 24-JAN-2018 STATED THAT THE PRODUCT WAS A TX11 SHEATH AND AT THE TIME, THE LOT NUMBER WAS NOT AVAILABLE. AS THE DOCTOR WAS PEELING THE SHEATH, IT GOT CAUGHT INSIDE THE PATIENT. IT WAS NOT KNOWN AT THE TIME HOW IT GOT CAUGHT, BUT WHEN THE SHEATH WAS OUT, THE TIP WAS MISSING. IT CONCLUDED THAT A VERY SMALL FRAGMENT OF THE SHEATH WAS LEFT INSIDE OF THE PATIENT. THERE WAS NO SECOND SURGERY OR MEDICAL INTERVENTION NEEDED TO REMOVE THE SHEATH. THE PATIENT WAS IN STABLE CONDITION AND DID NOT SUFFER ANY INJURY DUE TO THE INCIDENT. ADDITIONAL INFORMATION RECEIVED ON 12-MAR-2018 VIA MEDWATCH REPORT MW5075207 THAT STATED: ¿PATIENT HAD A POSTERIOR LUMBAR DECOMPRESSION LAMINECTOMY L2-L3 AND L3-L4. AFTER THE PROCEDURE, THE CIRCULATOR INFORMED PATIENT EXPERIENCE OFFICER (PEO) OF A PULL AWAY SHEATH TEAR DURING SURGERY. AT THAT TIME, HE NOTED MUCH RESISTANCE AND NOTIFIED THE OPERATING ROOM CIRCULATOR. THEY THEN CONTACTED THE ON-Q REPRESENTATIVE WHO STATED THAT THE DISTAL END OF THE PULL-AWAY SHEATH MAY HAVE BEEN PUNCTURED WHEN THE TROCAR WITH SHEATH IN PL

  Patient problems: Foreign Body In Patient

  MAUDE report 7397023 ↗
• MalfunctionDec 1, 2017Break; Break

  FILL VOLUME: 125 ML, FLOW RATE: UNKNOWN, PROCEDURE: TOTAL KNEE REPLACEMENT, CATHPLACE: POSTERIOR CAPSULE OF HIS KNEE. IT WAS REPORTED THAT CATHETER BREAK OCCURRED. THE CATHETER WAS PLACED BY THE ORTHOPEDIC SURGEON, FOLLOWING A TOTAL KNEE REPLACEMENT ON (B)(6) 2017. THE NURSE MET RESISTANCE WHEN TRYING TO REMOVE THE CATHETER AND THE PHYSICIAN ASSISTANT WAS PRESENT WHILE THE BREAK OCCURRED. THE PATIENT WAS STABLE AND WAS DISCHARGED WITH A PIECE OF CATHETER LEFT IN HIS POSTERIOR CAPSULE OF HIS KNEE. ADDITIONAL INFORMATION RECEIVED 13-NOV-2017 STATED THE PATIENT EXPERIENCED DISCOMFORT AS THE NURSE PULLED THE CATHETER, THE NURSE MASSAGED THE SKIN TO HELP RELEASE CATHETER. ABOUT 5 INCHES OF THE CATHETER WAS RETAINED IN THE PATIENT. NO PART OF THE CATHETER APPEARED GRAYISH DURING REMOVAL. NO ADDITIONAL INFORMATION REQUIRED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7076855 ↗
• InjuryNov 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: 400 ML. FLOW RATE: 4 ML/HR. INFUSION SCHEDULE: WAS TO INFUSE 85 CC/HR. PROCEDURE: REPAIR HERNIA INCISION, LAPAROSCOPIC INCISION VENTRAL W/ PRIMARY FASCIA. REAPPROX VENTRALITE ST 4.5" ROUND MESH SUBLAY PLACEMENT. CATHPLACE: RECTUS DIASTASIS - CATH PLACED BI-LATERAL SUBCOSTAL REGION AT LEVEL OF PREPERITONEAL SAC 2 SEPARATE EPIGASTRIC STAB INCISIONS, UTERAL INTRA-MUSCULAR SPACE USED FOR TAP BLOCK. IT WAS REPORTED THAT THE PATIENT HAD PAIN ON (B)(6) 2017. ON (B)(6) 2017, A COMPUTED TOMOGRAPHY SCAN REVEALED AN ABDOMINAL ABSCESS. OH THE (B)(6) 2017, THE SURGEON FELT THAT THE ISSUE WAS CAUSED BY THE CATHETER PLACEMENT. THE INFECTION WAS DIAGNOSED IN OFFICE AFTER REMOVAL OF THE CATHETER AS "STAPH AUREUS PRESENT, POSSIBLE MRSA WRITTEN IN NOTE" AND WAS DIAGNOSED ON (B)(6) 2017. THE PATIENT HAD TO HAVE AN INCISION AND DRAINAGE ON (B)(6) 2017. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "GOOD."

  Patient problems: Bacterial Infection

  MAUDE report 7004376 ↗
• MalfunctionOct 27, 2017Break; Break

  DATE OF INSERTION: (B)(6) 2017, DATE OF REMOVAL: (B)(6) 2017. A REPORT DOCUMENTED ON A MEDWATCH FORM, WAS RECEIVED AND DESCRIBING THAT THE PAIN BALL TUBING THAT WOULD NOT RELEASE FROM THE SITE. THE REMAINING PART OF THE TUBING WAS LEFT INSIDE OF THE PATIENT. "THE BALL (PAINBALL TUBING COULD NOT BE REMOVED. THE RN ATTEMPTED TO REMOVE WITH PATIENT LYING ON BACK, OR SIDE AND STANDING. THE RESIDENT ATTEMPTED REMOVED AND THE TUBING BROKE LEAVING THE REMAINING TUBING IN THE PATIENT. THE [DOCTOR WAS] AWARE AND STATED THE TUBING COULD BE LEFT IN THE PATIENT. THE OPTIONS WERE TO SNIP THE TUBING AND LEAVE IN THE BODY, LIDOCAINE TO REMOVE THE TUBING FROM THE BODY OR TO REMOVE FROM THE BODY. THE TUBING WAS LEFT IN THE BODY AND THE PATIENT DISCHARGED HOME." NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6984394 ↗
• MalfunctionAug 29, 2017Break; Break

  IT WAS INITIALLY REPORTED THAT A CATHETER BROKE. ADDITIONAL INFORMATION RECEIVED ON 04-AUG-2017 STATED THAT THE CATHETER BROKE OFF WHEN THE NURSE ATTEMPTED TO REMOVE IT FROM A PATIENT. AS A RESULT, THE PATIENT HAD TO RETURN TO SURGERY FOR REMOVAL OF THE BROKEN SEGMENT. IT WAS NOTED THAT THERE WAS NO DIFFICULTY EXPERIENCED WHEN INSERTING THE CATHETER. IT WAS SECURED WITH TEGADERM AND DRESSING, AND POUCH FOR BALL. DURING REMOVAL, THE RESISTANCE MET ON A SCALE OF 0-5 WAS A 5, AND THE BREAK HAD A CLEAN CUT APPEARANCE. IT WAS STATED THAT NO PERMANENT INJURY OCCURRED TO THE PATIENT. MEDWATCH REPORT MW5071292 WAS RECEIVED ON 16-AUG-2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6828424 ↗
• MalfunctionMay 11, 2017Break; Break

  A REPORT WAS RECEIVED FROM (B)(6) STATING A CATHETER SNAPPED UNDERNEATH THE SKIN DURING AN ARTHROSCOPIC SHOULDER DECOMPRESSION. THERE WAS NO REPORTED INJURY BUT A SECONDARY SURGERY WAS SCHEDULED TO REMOVE THE CATHETER. ADDITIONAL INFORMATION RECEIVED 26-APR-2017 STATING THAT THE CATHETER WAS SUTURED THROUGH AND WAS BROKE INSIDE OF THE PATIENT. A SECONDARY SURGERY WAS SCHEDULED TO REMOVE THE CATHETER. ADDITIONAL INFORMATION RECEIVED 27-APR-2017 STATING THIS OCCURRED DURING REMOVAL OF THE CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6559512 ↗
• MalfunctionMar 30, 2017Break; Device Or Device Fragments Location Unknown; Break; Device Or Device Fragments Location Unknown

  PROCEDURE: SPINAL SURGERY. A REPORT WAS RECEIVED STATING A T-PEEL BROKE INSIDE A PATIENT. DURING T-PEEL REMOVAL THE T-PEEL STRETCHED AND BROKE. ABOUT HALF OF THE T-PEEL WAS RETAINED INSIDE THE PATIENT. THE SURGEON DECIDED TO LEAVE THE BROKEN T-PEEL INSIDE THE PATIENT DUE TO THE POTENTIAL OF TEARING THE PARA SPINAL MUSCLES. THE SURGEON PULLED AND PEELED AT THE SAME TIME DURING THE REMOVAL. THE REMOVED PORTION OF THE T-PEEL WAS STRETCHED AND CURLED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6446621 ↗