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." this emdr covers the unknown number of catheters associated with the defect.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
The investigation covered aspects such as personnel, machinery, materials, methods, environment, and measurements (5m1e principle).Key findings include: personnel involved were adequately trained.Machines operated smoothly with no anomalies.Raw materials met inspection standards.The coating solution preparation and coating process followed standard procedures with no deviations.Temperature and humidity during production were stable and compliant.The batch passed outgoing inspection without abnormalities.The root cause was identified as environmental factors (high temperature or humidity) during transportation or storage, which likely caused the stickiness between the catheter and packaging.No corrective actions were planned for now, as the production process was deemed satisfactory.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092 manufacturing site: 3005471919.

• 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: 23726992
• Report Number: 1049092-2025-00301
• Device Sequence Number: 10628598
• 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: 24B10701
• 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: 12/18/2025
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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