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

Model Number	M12C
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	12/17/2024
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 reports "the catheters have white particles less than ¼ inch long that break up until smaller pieces that come out and attach to the catheter once removed from the packaging.He said the catheter itself is perfect the problem is the packaging.He said these white particles are coming off with the catheter from the catheter packaging or glue used to seal the packaging." end user is very upset about this concern however no actual harm was reported.This emdr covers the unknown lot numbers and market units associated with the reported defect.
Additional Manufacturer Narrative
Retains samples were checked but no similar particles have been found inside or outside the package.An in-depth investigation was carried, and the root cause was that some cutting blades of the blister packaging machine are worn out, resulting in products still been adhered after cutting.Workers at the packing line tore the products apart, packed them into the box, paper shaving are generated and adhere to the pouch, ultimately leading to the complaint.Action taken: longitudinal and transverse cutting blades of ybz013 has been replaced and regular replacement of the longitudinal and transverse cutting blades has been put in place and workers at the packing line have been trained.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 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: 21102989
• Report Number: 1049092-2025-00006
• Device Sequence Number: 15617528
• Product Code: EZD
• UDI-Device Identifier: 00815947020079
• UDI-Public: 00815947020079
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2024

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: M12C
• Device Lot Number: 23B19806
• 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: 12/17/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2023
• 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 Sex: Male