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

Model Number	M10
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
It was reported "foreign objects found sticking out of caths.Causing longer times to cath, issues at school, and other complaints." photos depicting the reported complaint issue were provided by the complainant.
Additional Manufacturer Narrative
Investigation findings · foreign object analysis: o two small foreign objects detected via images.O object 1: approx.0.3-0.4mm in length, color similar to catheter.O object 2: extremely small (0.03mm diameter), almost invisible.O no physical samples available, making identification difficult.O review of 13 retained samples showed no similar foreign objects.· production process review: · personnel: trained staff followed standard inspection procedures.· machines: extruder yjc005 functioned normally, filtering system prevents contamination.· materials: raw material passed quality checks.· method: inspection guidelines specify foreign objects must be [?]0.3mm² and [?]3 per catheter.· environment & cleaning: no issues found; standard cleaning protocols were followed.· measurement: factory process and outgoing inspections showed compliance.Final conclusion · no abnormalities detected in production.· no similar foreign objects found in retained samples or factory environment.· due to missing physical samples, the root cause couldn't be determined.· this issue appears to be an isolated incident, so no corrective or preventive actions were taken.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; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3367062840
• MDR Report Key: 21729869
• Report Number: 1049092-2025-00135
• Device Sequence Number: 15650919
• Product Code: EZD
• UDI-Device Identifier: 00815947020000
• UDI-Public: 00815947020000
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: M10
• Device Lot Number: 23B14902
• 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: 03/24/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 06/06/2025
• 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 Sex: Unknown