GENTLECATH GLIDE
Report
- Report Number
- 3005778470-2024-00275
- Event Type
- Malfunction
- Date Received
- January 23, 2024
- Report Date
- January 22, 2024
- Manufacturer
- UNOMEDICAL S.R.O.
- Product Code
- GBM
- PMA / PMN Number
- K181206
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
A2: SEX: FEMALE. 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 AND PACKAGING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO NONCONFORMITY HAD BEEN REGISTERED DURING THE PRODUCTION AND STERILIZATION PROCESS OF THE MENTIONED LOT. SIMILAR COMPLAINTS WERE RECEIVED ON THE LOT IN QUESTION. COMPLAINT WAS SUBMITTED TO COMPLAINT REVIEW BOARD. THE INCREASED TREND OF COMPLAINTS, RELATED TO THE POUCH PAPER TEARS UNEVENLY DURING OPENING, WAS OBSERVED. THEREFORE, CAPA 1832524 HAS BEEN RAISED TO ADDRESS THE ISSUE. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS, SOP-000741. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 1049092 . MANUFACTURING SITE: 3005778470.
END USER REPORTS PAPER TEARING UNEVENLY WHEN OPENING. THERE WAS NO HARM REPORTED.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 826280 | GENTLECATH GLIDE | CATHETER, URETHRAL | GBM | UNOMEDICAL S.R.O. | 421910 | 3C01306 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |