MAUDE Adverse Event Report: CONVATEC GENTLECATH GLIDE; CATHETER, URETHRAL

Model Number	421569
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
A2 age: 82 years, sex: male.E1 address: (b)(6).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: 3005778470.
Event or Problem Description
End user reports the paper backing on packaging of catheters are tearing as well when he pulls the tabs apart.He thinks the adhesive may be too strong on them but the paper is tearing unevenly when he goes to pull them apart.The packages "adhesive is tight super strong glue" causing the paper to tear he thinks.
Additional Manufacturer Narrative
A batch record review was conducted resulting in the following: urinary catheter in question was manufactured under sap material id (b)(4) and manufacturing lot # 3b02711 in c2 on packaging machine p020 in amount (b)(4)pcs.The product was packed according to the instruction for packing g905704 ver 24.0 pracovná in¿trukcia pre balenie gentlecath glide katétrov na p009/p006/p020.According to g905704 ver 24.0 within in-process the peeltest is carried out.5.11.3 peelpack must not be sealed so strong that paper residues remained on the foil or paper tears.Seal should be enough strong to keep paper and foil together without any irregularities.Test results are recorded in form 1, g906996 ver 1.0.Review of the dhr showed that all relevant tests required during the manufacturing packaging and process and final product release had been fulfilled and met the requirements.No nonconformity had been registered during the production process of the mentioned lot.One another complaint 1818919 of this nature has been received on the lot 3b02711.Non conforming product to each complaint ¿ 1pc.This issue will be monitored through the post market product monitoring review process, (b)(4).
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: GENTLECATH GLIDE
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): CONVATEC; 7815 national service road; suite 600; greensboro NC
• Manufacturer (Section G): CONVATEC; 7815 national service road; suite 600; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 18463655
• Report Number: 3005778470-2024-00003
• Device Sequence Number: 2984018
• Product Code: GBM
• UDI-Device Identifier: 30768455143550
• UDI-Public: 30768455143550
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K181206
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

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 Expiration Date: 01/01/2026
• Device Model Number: 421569
• Device Lot Number: 3B02711
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2023
• 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