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

Model Number	M14
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946)
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
It was reported "the patient had a catheter where the eyelets were not polished and cut him during insertion and caused bleeding.".
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Investigation summary: a.Man (personnel): all operators and inspectors were properly trained; no abnormalities in training records.B.Machine: machines yjg001/yjg003/yjg004 used for eyelet punching.Equipment maintenance, calibration, and parameter control were normal.Key parameters were password protected; no unauthorized adjustments.Visual inspection system in place: defective eyelets automatically rejected.C.Material: no material-related issues involved for this complaint.D.Method: first-article inspection conducted before mass production: no abnormalities.100% manual inspection of eyelets required; operators followed the work instructions.Ng (no good) box used at inspection station to prevent defective product mix in.E.Environment: no environmental factors involved.F.Measurement.In-process inspection every 2 hours per procedures; no defects recorded.Outgoing inspection also confirmed eyelets met appearance standards.3.Findings: 13 retained samples were examined microscopically and by touch: no burrs, sharp edges, or roughness detected.Eyelets met all appearance and quality requirements.No equipment malfunction, process deviation, or personnel error found.No similar complaints for the same batch were previously reported.4.Conclusion: manufacturing process was fully controlled; no abnormalities found.Current production lines showed no eyelet issues.Customer¿s report of bleeding is accepted as a real occurrence, but: insufficient information prevents deeper investigation.Specific defective catheter could not be evaluated.5.Root cause: root cause cannot be determined due to lack of evidence from the end user.6.Corrective / preventive actions: no corrective actions taken (cannot address root cause without evidence).Situation will continue to be monitored pending additional information.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: 24020036
• Report Number: 1049092-2026-00005
• Device Sequence Number: 10550616
• Product Code: EZD
• UDI-Device Identifier: 00815947020031
• UDI-Public: 00815947020031
• Combination Product (Y/N): N
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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: M14
• Device Lot Number: 25B13703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2025
• 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 Sex: Unknown