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 catheter tip is sealed with sealing of the primary package.".
Additional Manufacturer Narrative
Mdr 3005778470-2023-00339 / device 1 of 2.A1: sex: female.Based on the available information, this event is deemed to be a serious injury.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: (b)(6).Manufacturing site: 3005778470.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
The picture related to the complaint were provided and evaluated.The picture shows the pouch from back side therefore the defect is invisible and cannot be confirmed.The issue on the product is detectable during production.100% visual inspection with focus on the issue is carried out.Lot # 2a04342 was packed in february 2022 on packaging machine p006, total lot amount (b)(4) pcs.Review of the dhr lot 2a04342 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 previously.Capa tw (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 (b)(4), did not ensure 100% help to hold catheters on the right place in the cavities.Only reduce potential risk of catheters squeezing in weld.One another (b)(4) of this nature has been received on the lot.(b)(4).The following conclusion was made on the crb meeting: ¿the defect occurrence is small in each complaint.The defect is clearly visible and was detected by users before use.No harm was reported.According to ifu 1719466:.¿ do not use the device if the packaging or the water sachet is damaged or open prior to use and dispose of the device according to local regulations.No further actions are required at this stage.The issue will be continued to be monitored.In case of increased trend, the issue will be submitted to crb.¿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
• 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 ; 3365424679
• MDR Report Key: 18185034
• Report Number: 3005778470-2023-00339
• Device Sequence Number: 17803916
• Product Code: KOD
• UDI-Device Identifier: 30768455143567
• UDI-Public: 30768455143567
• Combination Product (Y/N): N
• 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: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

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: 12/01/2024
• Device Model Number: 421570
• Device Lot Number: 2A04342
• 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: 11/20/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• 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