MAUDE Adverse Event Report: UNOMEDICAL S.R.O. 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
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
Distributor reports the "paper on packaging tearing unevenly when opening.He checked multiple catheters from multiple mus he had in his supply store of 421569 and noted every single one he tried to open had the same issue.He noticed as he opened them by peeling the tabs apart, the paper was ripping anywhere from 1/4 of the way to 1/2 down." photos depicting the reported complaint issue were provided by the complainant.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Review of the dhr showed that all relevant tests required during the manufacturing and packaging process and final product release had been fulfilled and met the requirements.No nonconformity had been registered during the production and sterilization process of the mentioned lot.According to g905704 ver 24.0 within in-process the peeltest is carried out.Point 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.Review of test results ,recorded in form g906996v1.0, was carried out and all samples passed peeltest requirements.One similar complaint was received on the lot in question with pictures of boxes, where the defective catheters were found was provided.Complaint was submitted to complaint review board held on february 16th, 2024.-% affected pcs against the lot equals 0,75.Percentage of affected pcs reported within both complaints is above aql0, 4.Capa 1832524 has been raised to address the issue.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 3005778470.

• Brand Name: GENTLECATH GLIDE
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3,; michalovce 07101 ; LO 07101
• Manufacturer (Section G): UNOMEDICAL S.R.O.; priemyselny park 3,; michalovce 07101 ; LO 07101
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 18580874
• Report Number: 3005778470-2024-00282
• Device Sequence Number: 7076921
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2024

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: Other
• Device Expiration Date: 02/01/2026
• Device Model Number: 421569
• Device Lot Number: 3C04454
• 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): Follow-Up
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2023
• 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