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
Additional Manufacturer Narrative
E1: 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 or Problem Description
It was reported "catheter tip sealed with package".Photos depicting the reported complaint issue were provided by the complainant.
Additional Manufacturer Narrative
During complaint review, the increased number of complaints related to the issue - catheter squeezed in welding packaging, has been observed previously.A capa has been open to investigate the issue.Within the capa as immediate action operators were retrained in (b)(6) 2023 on visual inspection that is focused on the reported defect.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.Two other complaints of this nature has been received on the lot.Due to ongoing monitoring the issue was submitted to crb that held on (b)(6) 2023.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.
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): 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: 18662685
• Report Number: 3005778470-2024-00435
• Device Sequence Number: 7194670
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024

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: 02/07/2024
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 03/18/2024
• 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