GENTLECATH GLIDE
Report
- Report Number
- 3005778470-2024-00709
- Event Type
- Malfunction
- Date Received
- February 22, 2024
- Report Date
- February 20, 2024
- Product Code
- GBM
- PMA / PMN Number
- K181206
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
MDR 3005778470-2024-00709 DEVICE 2 OF 34. A2: SEX: MALE. 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.
THIS COMPLAINT HAS BEEN EVALUATED AS A TYPE 2 CASE. NO PHOTOS OR SAMPLES WERE PROVIDED TO THIS COMPLAINT. A BATCH RECORD REVIEW WAS CONDUCTED. NO NONCONFORMITY HAD BEEN REGISTERED DURING THE PRODUCTION AND STERILIZATION PROCESS OF THE MENTIONED LOT. ONE SIMILAR COMPLAINT WAS RECEIVED ON LOT WITH THE SAME ISSUE. BASED ON INCREASED TREND OF RECEIVED COMPLAINTS WAS OPENED NEW CAPA#1832524 - INCREASED COMPLAINT TREND RELATED TO THE ISSUE PEELPACK PAPER TEARING UNEVENLY WHEN OPENING GENTLECATH GLIDE. CAPA OPENED 20/FEB/2024 AND IT IS IN INVESTIGATION STATE. 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 BACKING DID NOT PEEL AS IT SHOULD BUT TORE WHEN OPENED. 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 |
|---|---|---|---|---|---|---|---|
| 1416267 | GENTLECATH GLIDE | CATHETER, URETHRAL | GBM | 421910 | 3C04450 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |