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

Model Number	HM12C
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
End user's wife reports "catheters are not peeling open evenly, it is like the catheters packaging has adhesive issues or paper issues.The paper will stick to one or both of the sides and tear as she is peeling it open and paper will tear unevenly.".
Additional Manufacturer Narrative
Mdr 1049092-2026-00031 / device 14 of 25.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
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Investigation scope and approach: investigation conducted using 5m1e (man, machine, material, method, measurement, environment) methodology.Included: retained sample testing.Comparison with customer photos.Review of production, inspection, sterilisation, and environmental records.Root cause conclusion direct root cause: uneven tearing and paper debris occur only when the pouch is torn horizontally with the paper side facing upward.The issue is related to the tearing angle and force applied to the paper, reflecting an inherent characteristic of the paper material, not a manufacturing defect.No evidence supports a production, material, machine, sterilisation, or inspection failure.Uti consideration: while the uti was temporally associated with the product use, the investigation did not establish a causal link between product sterility or manufacturing defects and the infection.Product sterility and packaging integrity at release were confirmed.Corrective / preventive actions: no capa initiated, as no manufacturing nonconformance was identified.User guidance reinforced.After bursting the water sachet, keep the pouch vertical to fully wet the catheter.Tear the pouch vertically (as shown in the ifu) to minimize paper tearing and debris.Final conclusion: the product meets all quality, inspection, and sterility requirements.The complaint is attributed to use-related tearing method, not a manufacturing defect.Recommendation focuses on correct pouch-opening technique per ifu to improve user experience and reduce perceived risk.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: courtney smith ; 7815 national service road; suite 600; greensboro, NC 27409 ; 6032470255
• MDR Report Key: 24233164
• Report Number: 1049092-2026-00031
• Device Sequence Number: 18689182
• Product Code: EZD
• UDI-Device Identifier: 00815947020338
• UDI-Public: 00815947020338
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: HM12C
• Device Lot Number: 25B06401
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• 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: 79 YR
• Patient Sex: Male