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

Model Number	421910
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
Event or Problem Description
End user reports in the current market unit he has already found qty 2 misaligned is lot 5a00617.He "caths 5 x a day for retention from bph.He states the coude tip and the notch on the funnel end are not perfectly aligned on all catheters.He said this is misaligned by varying degrees, mentioning some are off by 20 degrees sometimes 90 degrees or sometimes even more than 90 degrees.He said 60-70% of them are all aligned well in all his orders but the rest are not.He said when he first started cic and using this product, again about 3-4 yrs ago, he did not realize this misalignment issue and said he remembers it was painful and uncomfortable with insertion of one and felt like there was a sharpness when he was inserting and did say he did experience a "little bit of bleeding" which resolved shortly.He then saw it was due to the misalignment.He knows to keep the coude tip up when inserting and at the time, he was relaying on the notch.He said he learned really quick to not rely on the notch on the funnel and just takes account the misalignment to keep the coude tip itself pointing upwards with insertion and then they work fine for him.".
Additional Manufacturer Narrative
Device 1 of 2 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
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 process, packaging process and final product release had been fulfilled and met the requirements.No nonconformances were identified for this lot.No similar complaint has been received for lot 5a00617 and malfunction code uca-pmc07.04.01 ¿ incorrect coude tip alignment (relative to markings) for gentlecath glide.The urinary catheters were produced in january 2025.All raw materials used in the production of the affected lots were verified to be correct and within specification.No nonconformances were identified during the production of these lots.All raw materials used in the production of the affected lots were verified to be correct and within specification.No nonconformances were identified during the production of these lots.According to process instruction the indicator on the connector must be positioned correctly depending on the orientation of the bent end of the tubing.The orientation of the connector must be in accordance with the drawing and instruction.Process and quality checks were performed and documented in accordance with standard procedures.Capa tw#1672354 was opened in (b)(6) 2022 for incorrect coude tip alignment.As part of the corrective actions, the tolerances for the tip/funnel indicator control were tightened.Lot 5a00617 was produced after implementation of all capa actions.Should additional information become available, a follow-up report will be submitted.Fda registration number.Reporting site: 1049092.Manufacturing site: 3005778470.

• Brand Name: GENTLECATH
• 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: courtney smith ; 7815 national service road; suite 600; greensboro, NC 27409 ; 6032470255
• MDR Report Key: 24631684
• Report Number: 3005778470-2026-00527
• Device Sequence Number: 21078991
• Product Code: GBM
• UDI-Device Identifier: 30768455153825
• UDI-Public: 30768455153825
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup

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: 421910
• Device Lot Number: 5A00617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2025
• 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: Male