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

Model Number 421571

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Device 5 of 5.E.1: complainant city: (b)(6).Complainant state/province: (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 Description

It was reported the catheter tip is sealed with primary package.The product was not used.Photos depicting the reported complaint issue were provided by the complainant.

Event Description

To date no additional patient or event details have been received.

Manufacturer Narrative

The pictures related to the complaint were provided and evaluated.The defect reported was confirmed.The complaint confirmed based on the picture.The issue on the product is detectable during production.100% visual inspection with focus on the issue is carried out.Lot # 2h01637 was packed in september 2022 on packaging machine p006, total lot amount (b)(4).Review of the dhr lot 2h01637 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 (b)(4) has been open to investigate the issue.Within the capa as immediate action operators were retrained in may 2023 on visual inspection that is focused on the reported defect.Was determined that cpm slightly increased, but the incidence of defect occurrence is not high.Lot in question was produced before the retraining was carried out.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.No another complaint of this nature has been received on the lot.The defect rates should be (b)(4) based on g805118 general quality requirements, class a1 nonconformities - welding must be intact all the way round.For lot 2h01637 -- the defect rate is (b)(4) units reported out of produced (b)(4) pcs unit equivalents to (b)(4).This issue will be continued to be monitored.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.

• Brand Name: GENTLECATH GLIDE
• Type of Device: 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: 17816300
• MDR Text Key: 324223140
• Report Number: 3005778470-2023-00210
• Device Sequence Number: 1
• Product Code: GBM
• UDI-Device Identifier: 30768455143574
• UDI-Public: 30768455143574
• Combination Product (y/n): N
• PMA/PMN Number: K161344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 421571
• Device Lot Number: 2H01637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1