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

Model Number	421570
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the tip of the urinary catheter is caught in the packaging.There were no photos provided.There was no harm reported.
Additional Manufacturer Narrative
Device 3 of 3.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
No photo or samples have 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 1718760 - gentlecath glide fem ch08 (1x30pk) eur and manufacturing lot#2l02753 in amount (b)(4) pieces in center c2 in december 2022 on packaging machine p006.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.Review of the dhr showed that all relevant tests required during the manufacturing, packaging and sterilization process had been fulfilled and met the requirements.No nonconformity had been registered during the production process of the mentioned lot.One another complaint was received to lot#2l02753 and malfunction code "uca-pmc11.16 difficult to remove catheter from primary pack during use" - (no photo, 3 affected pieces) to april 10, 2025.Also one complaint was received to this lot and malfunction code "uca-pmc11.07 primary pack has incomplete or open seal / weld, or is torn, ripped damaged, split, cracked or crushed or contains holes or exhibits external contamination (e.G.Water marks, stains), or dressing or loose material is trapped in packaging" (photo attached, 1 affected piece).According to g905704 v.24.0, point 5.11.9 ¿ no welded catheters in peelpack are allowed.Visual inspection is provided according to tm-437 v.1.0.During production of lot#2l02753 all test have been carried out, and no discrepancies were found.According to sec.5.17.10 packaging coordinator ¿ final check of catheters ¿ no welded catheters are allowed.Final check is provided according to il s2, aql 0,65 to inspect products in peelpacks.Control is provided in compliance with tm-437 v.1.0 and results are recorded in g905704 form 2.The percentage of affected pieces against lot is 0,001%.Affected quantity is within aql 0,65.This issue will be monitored through the post market product monitoring review process, sop-000741.
Additional Manufacturer Narrative
No photo or samples have 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 1718760 - gentlecath glide fem ch08 (1x30pk) eur and manufacturing lot#2l02753 in amount (b)(4) pieces in center c2 in december 2022 on packaging machine p006.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.Review of the dhr showed that all relevant tests required during the manufacturing, packaging and sterilization process had been fulfilled and met the requirements.No nonconformity had been registered during the production process of the mentioned lot.One another complaint was received to lot#2l02753 and malfunction code "uca-pmc11.16 difficult to remove catheter from primary pack during use" - (no photo, 3 affected pieces) to april 10, 2025.Also one complaint was received to this lot and malfunction code "uca-pmc11.07 primary pack has incomplete or open seal / weld, or is torn, ripped damaged, split, cracked or crushed or contains holes or exhibits external contamination (e.G.Water marks, stains), or dressing or loose material is trapped in packaging" (photo attached, 1 affected piece).According to g905704 v.24.0, point 5.11.9 - no welded catheters in peelpack are allowed.Visual inspection is provided according to tm-437 v.1.0.During production of lot#2l02753 all test have been carried out, and no discrepancies were found.According to sec.5.17.10 packaging coordinator - final check of catheters - no welded catheters are allowed.Final check is provided according to il s2, aql 0,65 to inspect products in peelpacks.Control is provided in compliance with tm-437 v.1.0 and results are recorded in g905704 form 2.The percentage of affected pieces against lot is (b)(4).Affected quantity is within aql 0,65.This issue will be monitored through the post market product monitoring review process, (b)(4).
Event or Problem Description
To date no additional patient or event details have been received.

• 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): CONVATEC; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3367062840
• MDR Report Key: 21780667
• Report Number: 3005778470-2025-00506
• Device Sequence Number: 8636190
• Product Code: KOD
• UDI-Device Identifier: 30768455143567
• UDI-Public: 30768455143567
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K181206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2025

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 Expiration Date: 10/01/2025
• Device Model Number: 421570
• Device Lot Number: 2L02753
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 04/14/2025; 04/14/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 04/24/2025; 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/23/2022
• 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