CURE CATHETER CLOSED SYSTEMRecalls & reported problems across all models

We found 4 models of CURE CATHETER CLOSED SYSTEM by Convatec, Purchasing Department in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Nov 6, 2020 and Sep 16, 2026 — classified as 6 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (19 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CURE CATHETER CLOSED SYSTEM problems

CURE CATHETER CLOSED SYSTEM models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CURE CATHETER CLOSED SYSTEM CS12

  Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
  22 reports
• CURE CATHETER CLOSED SYSTEM CS14

  Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
  6 reports
• Cure Catheter® Closed System CS10

  Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
  1 report
• CURE CATHETER CLOSED SYSTEM CS14C

  Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
  1 report

Recent CURE CATHETER CLOSED SYSTEM adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Device Handling Problem

  End user states "He said some would go in the first inch and will fold back, some others won't go in his urethra at all as they are too flexible. He has no stricture/scar tissue he is aware of. Others he could not pass his prostate and some fold at this point and others just won't pass as they lack the rigidity that he is used to with this product. He said at times it will be 5 in a row that won't go in and then he will try another one and have no problems at all. He said he will go weeks without this being an issue and then he will get another 3 in a row that will give him the same trouble. He said due to the trouble of not being able to pass a few he did experience bleeding. He does not bleed often but states he is prone to UTIs with bleeding events. The bleeding was slight and only was noted on ends of catheters and a little on a pad before stopping on its own. After he had malodorous urine and cloudy urine and went to see his infectious disease MD. They checked his urine and he was found to have a UTI and prescribed a week treatment dose of Bactrim which cleared up his symptoms. He said they checked his PSA and his prostate and nothing appeared too swollen. He has regular follo

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Urinary Tract Infection

  MAUDE report 50789141 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681889 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681867 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681793 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681703 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681676 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681656 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681604 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681551 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24676217 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24676207 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675893 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675839 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675760 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675708 ↗

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