MAUDE Adverse Event Report: CONVATEC INC CURE CATHETER; CATHETER, STRAIGHT

Model Number	HM16C
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092 manufacturing site: 3005471919.
Event or Problem Description
End user reports he caths 4-6 times a day for retention.He said "he gets 540 catheters at a time as he gets a 3 month order at a time.When he first got this order (he is nearly done with as he only has 2 boxes left) a few months ago, he said he noted this concern and has continued to use them.He estimates about 1/3 to 1/2 of this entire order so far was affected.He noted 2 different lots he found catheters with the same issue in but did not know how many of each mu box per lot he received.He said the tip end of the catheters are stuck in the seal of the packaging, so this makes them stuck inside when he goes to remove them from packaging after prepping them.He said he has to "yank them" out of packaging.He said due to this, the tip is affected as it doesn't feel as smooth as it should, feels like something tiny is sticking to the tip.He said going in it is ok, not too much discomfort but upon removal, it will feel it scratching the length of his urethra only on these that are affected.Has never had any bleeding with use of these even with reported defect or any lasting harm he said.".
Additional Manufacturer Narrative
A full 5m1e investigation was conducted to determine whether production contributed to the sticking issue.Key findings man all operators and inspectors were trained, certified, and competent.No deviations in personnel performance.Machine coating machines ytc004 / ytc005 / ytc007 operated normally during (b)(6) 2025.No alarms, downtime, or abnormal process parameters.Material primer (112754e) and topcoat (115677p) passed incoming inspection and were released correctly.Method / measurement coating preparation, viscosity checks, labeling, and 48 hour usage limits were followed.Coating process and inspection records (first article + in process) met all requirements.Each catheter was inspected for roughness, eyelet blockage, coating uniformity, curing, and tackiness¿no abnormalities found.Required 24 hour hanging time after coating was correctly executed.Environment pouch uses medical grade dialysis paper, which is porous.High humidity can allow moisture to penetrate the pouch, causing sticking between catheter and pouch.Packaging area humidity records showed no excursions during production.Measurement (final qc) process and outgoing inspection records were compliant.Conclusion no production related abnormalities were identified.Sticking is attributed to the inherent porosity of the dialysis paper, which allows moisture ingress under high humidity storage or transport conditions.This is a known characteristic previously addressed in scar2188068 escalated to capa 2226865 with, no further actions required at the moment.Root cause moisture penetration through the porous dialysis paper when exposed to high humidity for extended periods, leading to catheter¿pouch adhesion.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092 manufacturing site: 3005471919.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: CURE CATHETER
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 23726870
• Report Number: 1049092-2025-00298
• Device Sequence Number: 13430084
• Product Code: EZD
• UDI-Device Identifier: 00815947020352
• UDI-Public: 00815947020352
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: HM16C
• Device Lot Number: 25B04104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male