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

Model Number	421566
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
Device 19 of 22.Based on the available information, this event is deemed to be a reportable malfunction.A batch record review was conducted resulting in the following: this lot was manufactured in february 2025 with quantity of (b)(4) pieces.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 nonconformance's were identified for this lot.No similar complaint was received for this lot and malfunction code.The machine logbook was reviewed, and no records related to this issue were found.Additionally, no ncs were identified during the sterilization process.The percentage of affected pieces against the lot is (b)(4) percent (a total of 22 affected pieces out of (b)(4) produced).The affected quantity is within the aql 0.65 limit.This complaint was presented on complaint review board on february 5, 2026.Attendees decided that this is considered an isolated issue and no further actions are required.The catheter in question was not used.Operators will be retrained according to g708002 education and training of production personnel (current version) and the issue will be presented to operators according to wi-001366 qa data visualization (current version).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
It was reported upon opening the packages, "dark reddish stains were found on the tapered tip of the catheter." photos depicting the reported complaint issue were provided by the complainant.

• Brand Name: GENTLECATH GLIDE
• Common Device Name: CATHETER, UROLOGICAL
• 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: 24277726
• Report Number: 3005778470-2026-00253
• Device Sequence Number: 8318406
• Product Code: KOD
• UDI-Device Identifier: 30768455143536
• UDI-Public: 30768455143536
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/31/2026

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: Health Professional
• Device Model Number: 421566
• Device Lot Number: 5B00763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2025
• 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 Sex: Unknown