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

Model Number	421565
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant state: (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
It was reported that the catheter tip was sealed with package.
Additional Manufacturer Narrative
The pictures were provided that showed the catheter was squeezed.The defect reported was confirmed that the catheter tip was sealed with package.The issue on the product is detectable during production.100% visual inspection with focus on the issue is carried out.Review of the dhr lot 2e02729 showed that all relevant tests required during the manufacturing and packaging process and final product release had been fulfilled.No nonconformity related to the issue reported had been registered during the packaging process of the mentioned lot.During complaint review , the increased number of complaints related to the issue - catheter squeezed in welding packaging, has been observed.Capa tw (b)(4) has been open to investigate the issue.Within the capa as immediate action operators were retrained on visual inspection that is focused on the reported defect.It was determined that cpm slightly increased, but the incidence of defect occurrence is not high.No harm was reported.The defect is visible and was detected before use.The corrective action implemented previously, that covered implementation of guides under ccr-dmr-00059, did not ensure 100% help to hold catheters on the right place in the cavities.Only reduce potential risk of catheters squeezing in weld.The defect rates evaluated for each lot are within an appropriate aql for above mentioned failure modes which should be 0.4% based on (b)(4) general quality requirements, class a1 nonconformities -welding must be intact all the way round.For lot 2e02729 - the defect rate is 1 unit reported out of produced (b)(6) pcs units equivalents to 0.0013 %.No additional action is required and this complaint will be closed.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 ; 3365424679
• MDR Report Key: 16713201
• Report Number: 3005778470-2023-00104
• Device Sequence Number: 16569129
• Product Code: GBM
• UDI-Device Identifier: 30768455143529
• UDI-Public: 30768455143529
• Combination Product (Y/N): N
• 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: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2023

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: 04/01/2025
• Device Model Number: 421565
• Device Catalogue Number: 421565
• Device Lot Number: 2E02729
• 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): Initial
• Initial Date Received by Manufacturer: 04/07/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2022
• 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: Unknown