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

Model Number	M12C
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
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 states "white paper particles/ dust in boxes and gets on catheters if he opens them." this emdr covers the unknown number of catheters associated with the defect.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Investigation findings: 1.Complaint history: first complaint (jan 2025): significant paper debris attached to catheter.Second complaint (sep 2025): minor paper scraps on pouch, less severe than first incident.2.Sample & site inspection: retained samples: 2 out of 13 showed minor paper scraps; no major accumulation.Workshop inspection: noticeable reduction in paper debris around equipment since first capa.3.5m1e root cause analysis: man: all packing staff trained and compliant with inspection protocols.Machine: ybz003 blister packing machine used.No equipment faults; parameters within spec.Blade wear after ~2 months caused increased paper scraps.Material: issue due to mechanical cutting, not material quality.Method: sops were clear and followed; blade wear not detected early.Environment: no changes.Measurement: final inspection records showed all products passed.Root cause: premature blade wear on ybz003 machine during apr¿may 2025 led to increased paper scraps during pouch cutting, which transferred to the product.Corrective & preventive actions (capa) implemented: blade replacement: shifted from fixed 3-month cycle to dynamic + scheduled replacement.Inspection protocols: 100 percent inspection for foreign particles.Dust control: suction devices installed.Training: reinforced for packing staff.Ongoing improvements: differentiated blade cycles: adjusted per machine usage (e.G., ybz013 to monthly).Proactive monitoring: operators report scrap increase immediately.Customer communication: enhanced feedback loop and transparency.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: 22728480
• Report Number: 1049092-2025-00214
• Device Sequence Number: 13009235
• 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): 08/05/2025

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: M12C
• Device Lot Number: 25B06702
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• 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: Male