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

Model Number	HM16
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
End user states he received a new hm16 box and "he prepped it per ifus and did not use it to cath himself with but wanted to see if this same defect was occurring in a different lot as well." he only tested 1 from this box.He said he felt the eyelets with his hand and noted that yes "it seemed somewhat affected" feeling roughness along eyelets but not as bad as others he felt in the past of the lot as previously reported.
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: 1.Sample inspection: retained samples from the reported lot numbers (24b07901 & 23b14503) were visually and manually examined.No defects were found.2.Production analysis: a manufacturing issue was identified¿during production of lot 24b07901, a tool crack occurred, leading to a small number of defective products potentially entering normal production.This was not detected in the subsequent quality checks.3.Quality control review: training records confirmed personnel were properly trained, and inspection processes were in place.However, in-process inspections may have missed the defects.4.Corrective actions: steps were taken to prevent similar issues, including: ¿ retraining staff on inspection and handling of potential defects.¿ enhancing inspection methods, requiring personnel to use both visual and tactile checks.¿ implementing better tracking when abnormalities occur in production.Conclusion: the root cause was traced to the tool crack in lot 24b07901, which led to defective products being released.Quality control failed to detect these during inspection.The company has committed to improving inspection protocols and monitoring product quality more closely.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 LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 21365155
• Report Number: 1049092-2025-00057
• Device Sequence Number: 15566422
• Product Code: EZD
• UDI-Device Identifier: 00815947020321
• UDI-Public: 00815947020321
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 02/10/2025

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: HM16
• Device Lot Number: 23B14503
• 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: 02/10/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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: 84 YR
• Patient Sex: Male