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

Model Number	M14U
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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, an 85 yr old man, reports an oddity with only one of his usual catheters in his most recent box.He said one of the catheters has what looks like tiny black streaks and tiny dots on the inside packaging on the inside of the sealed packaging on the paper side.He said he didn't open the packaging but could see these tiny black marks through the clear part of the packaging.He said these marks are on one side of the packaging, by the eyelet end of the catheter.He said it doesn't look like any printing on the outside bled through in any way.He said there is about 5 black streaks along with a few tiny little dots and he estimates them to range from 1/8th to 1/16th of an inch long.A photo was provided.There was no harm reported.No additional information was provided.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Investigation: this complaint has been evaluated.Per supplier investigation, thirteen retain samples were inspected with no black stains found.No abnormalities noted in dhr.The investigation also examined man, machine, material, method, environment, measurement.Four major issues were identified in the blister packaging process: - missing equipment protection, exposed lubricating oil.- incomplete work instructions, no contamination control guidance.- pfmea gaps, contamination risks not identified.- occasional inspection miss, defect escaped full visual check.The complaint was determined to be an occasional event caused by catheter contact with exposed lubricating oil on the blister packaging machine.Multiple systemic gaps (equipment protection, work instructions, pfmea coverage, inspection oversight) contributed to the defect escaping to the customer.Corrective actions have been initiated including retraining outsourced inspectors and increasing patrol frequency.Fda registration number reporting site: 1049092.Manufacturing site: 3005471919.

• Brand Name: CURE CATHETER
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): CONVATEC; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer (Section G): CONVATEC; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer Contact: pam meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; +1(603)247-0255
• MDR Report Key: 25445526
• Report Number: 1049092-2026-00150
• Device Sequence Number: 9613847
• Product Code: EZD
• UDI-Device Identifier: 00815947020123
• UDI-Public: 00815947020123
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2026

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: M14U
• Device Lot Number: 25B22405
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Supplement Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 08/27/2026
• Date Device Manufactured: 08/01/2025
• 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: 85 YR
• Patient Sex: Male