MAUDE Adverse Event Report: CONVATEC LTD CURE PRODUCTS; CATHETER, STRAIGHT

Model Number	HM14C
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
Event or Problem Description
End user reports "in his most recent new box the first one he went to use was stuck but able to remove from the packaging pulling hard and said when he used it to cath with, the eyelets felt rough thinking that whatever substance was sticking the catheter to the packaging caused "some stuff sticking out" from the eyelets area and cause him bleeding with use.Bleeding lasted for a few hours (2 -4 hrs), dripping before dissipating on it's own without intervention.".
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.
Additional Manufacturer Narrative
Investigation findings · retained sample tests (b)(4) units) showed no abnormalities[?] all catheters were removable within 30 seconds of bursting the water sachet, and tip bending remained within standard range.· production review of coating process and tip forming found no issues: · personnel were properly trained and qualified.· machines (ytc005/007/008/011 for coating, ybk024/027 for tip forming) were fully functional during the production period.· coating materials and application procedures met quality standards.· process inspections every 2 hours showed no defects.· factory outgoing inspection confirmed compliance with product specifications.Final conclusion · no abnormalities detected in production or inspection processes.· possible causes: o sticky packaging may have resulted from storage or transportation conditions (e.G., high humidity or temperature).O tip bending could be within acceptable variation, but some units may have reached the upper limit.O due to lack of physical samples, images, and detailed usage information, the root cause of user bleeding remains unclear.No corrective action planned, as the manufacturing process was found to be within standard requirements.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 PRODUCTS
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer (Section G): CONVATEC; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3367062840
• MDR Report Key: 21468387
• Report Number: 1049092-2025-00113
• Device Sequence Number: 3391335
• Product Code: EZD
• UDI-Device Identifier: 00815947020345
• UDI-Public: 00815947020345
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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: HM14C
• Device Lot Number: 24B00204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• 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