MAUDE Adverse Event Report: UNOMEDICAL S.R.O. GENTLECATH GLIDE; CATHETER, URETHRAL

Model Number	421569
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1: (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 reported he has been cathing since 2012 following diagnosis of bph and a turp surgery.He reported he placed one catheter and it hurt more than normal and he took it out, ran his fingers down it and said when he ran his fingers by the tip, by the eyelets area "it felt really pretty rough" like they weren't polished well.He said he prepped it properly and said as he just started examining the catheters in the box and he estimates about half catheters in the box were like that.He said they felt rough by eyelets prior to bursting water sachet and after.He discarded them.
Additional Manufacturer Narrative
Review of the dhr showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements.The process parameters were adjusted within the validated window.No nonconformity has been registered during the manufacturing process of the affected lot and of the mentioned issue.No complaint was received on lot# 4a05391 and this type of issue.According to g805311 v.28.0, sec.5.12.4.Visual and tactile check of eyelets ¿ no threads and/or frayed edges, slugs/ punch outs are allowed and eyelets have to be smooth.Check of eyelets is provided according to tm-356, ver.3.0 and tests results have been recorded in g905311 form 3.The percentage of affected pieces against lot is (b)(4).This complaint was presented to the complaint review board on december 12, 2024.This is considered an isolated issue.Attendees decided that no further action are required.Operators will be retrained according to g708002 education and training of production personnel and the issue will be presented to operators according to (b)(4) qa data visualization.No additional details have been provided to date.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
To date no additional patient or event details have been received.

• 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 27409 ; 3365424679
• MDR Report Key: 20727954
• Report Number: 3005778470-2024-01052
• Device Sequence Number: 15529860
• Product Code: GBM
• UDI-Device Identifier: 30768455143550
• UDI-Public: 30768455143550
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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 Model Number: 421569
• Device Lot Number: 4A05391
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2024
• 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: Male