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

Model Number	421573
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: 3005778470.
Event or Problem Description
End user is a 70-yr old female, reports '1/2 inch live darker colored live worms found in packaging of catheters' in (b)(6) (lot # unknown) and in (b)(6) (lot# available).End user who has been using this product for 4 yrs, gets 5 boxes monthly.She said she first noticed this concern in a shipment in (b)(6) of this year and then earlier this week in a box.She said the worms she could see through the packaging in both cases and looked to be the same kind/ species of worm as they were the "same form".They are long (about half an inch) and slender and "looked like a little worm" seen through the packaging.She did not see any holes on any of the packaging at all/ all was intact and per her description it looked like the worms were packaged inside the sealed catheter packaging.She mentioned the worms she saw in june looked to be alive as they were wiggling and darker in color compared to the dead worm which was lighter beige in color she found in august.She did not use any of these but was able to note the lot number on that catheter prior to discarding it.Photos were provided.This report captures malfunction observed in the august delivery.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Investigation: this complaint has been evaluated as a type 2 case.No photo has been received to this complaint.A batch record review was conducted resulting in the following: urinary catheter in question was manufactured under sap material id 1713720 - gentlecath glide fem ch14 and manufacturing lot#5a00313 in amount (b)(4) pieces in center c2 on the packaging machine p006.Review of the dhr showed that all relevant tests required during the manufacturing process, packaging process and final product release had been fulfilled and met the requirements.No nonconformity has been registered during the manufacturing process of the mentioned lot# 5a00313.No another complaint has been registered to this lot and malfunction code "uca-pmc09.02 foreign matter within product".No nonconformity related to the issue reported had been registered during the sterilization process of the mentioned lot.According to g905704 v.30.0, point 5.11.16 ¿ peelpack without foreign matters.Visual inspection is recorded on g905704 form 3.During the production of lot# 5a00313, all tests have been carried out, and no discrepancies were found.According to sec.5.20.4 quality assistant ¿ products and components in all peelpacks in the inner box are present and in compliance with the job ticket and are not damaged.Visual inspection is recorded on g905016 form 2.Final check of inner boxes and products is provided according to il s3, aql (b)(4) to inspect products in peelpacks.The potential root cause is product storage or transportation the percentage of affected pieces against lot is (b)(4).Affected quantity is within aql (b)(4).This issue will be monitored through crb and the post market product monitoring review process, (b)(4).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 27409 ; 3365424679
• MDR Report Key: 22862413
• Report Number: 3005778470-2025-00726
• Device Sequence Number: 9339041
• Product Code: GBM
• UDI-Device Identifier: 30768455143581
• UDI-Public: 30768455143581
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161344
• 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): 08/14/2025

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: 421573
• Device Lot Number: 5A00313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 09/11/2025
• Date Device Manufactured: 01/02/2025
• 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 Age: 70 YR
• Patient Sex: Female