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

Model Number	HM16C
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported " over 50% of the box tips welded to pkg".
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
The investigation covered aspects such as personnel, machinery, materials, methods, environment, and measurements (5m1e principle).Key findings include: personnel involved were adequately trained.Machines operated smoothly with no anomalies.Raw materials met inspection standards.The coating solution preparation and coating process followed standard procedures with no deviations.Temperature and humidity during production were stable and compliant.The batch passed outgoing inspection without abnormalities.The root cause was identified as environmental factors (high temperature or humidity) during transportation or storage, which likely caused the stickiness between the catheter and packaging.No corrective actions were planned for now, as the production process was deemed satisfactory.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.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
The investigation covered aspects such as personnel, machinery, materials, methods, environment, and measurements (5m1e principle).Key findings include: · personnel involved were adequately trained.· machines operated smoothly with no anomalies.· raw materials met inspection standards.· the coating solution preparation and coating process followed standard procedures with no deviations.· temperature and humidity during production were stable and compliant.· the batch passed outgoing inspection without abnormalities.The root cause was identified as environmental factors (high temperature or humidity) during transportation or storage, which likely caused the stickiness between the catheter and packaging.No corrective actions were planned for now, as the production process was deemed satisfactory.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: (b)(4).Manufacturing site: (b)(4).

• 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: 21503524
• Report Number: 1049092-2025-00114
• Device Sequence Number: 20838302
• Product Code: EZD
• UDI-Device Identifier: 00815947020352
• UDI-Public: 00815947020352
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2025

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: HM16C
• Device Lot Number: 24B10701
• 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: 02/27/2025
• Supplement Date Received by Manufacturer: 04/17/2025; 04/17/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 04/24/2025; 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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