FOLYSIL SILICONE CATHETER
Report
- Report Number
- 9610711-2025-00035
- Event Type
- Injury
- Date Received
- February 21, 2025
- Date of Event
- January 10, 2025
- Report Date
- June 6, 2025
- Manufacturer
- COLOPLAST A/S
- Product Code
- EZL
- UDI-DI
- 03600040127230
- PMA / PMN Number
- K233411
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS NOT YET COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED ON COMPLETION OF THE INVESTIGATION.
A LOT NUMBER IS AVAILABLE IN THE DESCRIPTION, IT IS A LOT NUMBER USED IN THE UNIT BUT THE INCRIMINATED LOT NUMBER IS NOT KNOWN. WE HAVE CHECKED THE LOT NUMBER ON THE DESCRIPTION AND BASED OUR DOCUMENTARY INVESTIGATION ON THIS LOT, EVEN IF IT'S NOT THE INCRIMINATED LOT. WE SEARCHED FOR OTHER COMPLAINT REGARDING THE LOT NUMBER IN DESCRIPTION AND WE DIDN'T FIND OTHER COMPLAINT REGARDING THE LOT NUMBER 9792211. ON 18TH FEBRUARY 2025, WE RECEIVED ONE USED SAMPLE. WE ONLY RECEIVE ONE PART OF TUBE WITHOUT VALVE SO NO TEST OF INFLATION/DEFLATION CAN BE DONE. THE TUBE OF THE CATHETER WAS CUT PROBABLY WITH A SHARP MATERIAL. HOWEVER ACCORDING TO THE INFORMATION RECEIVED IT WAS MENTIONED THAT THE BALLOON WAS INFLATED WITH 12ML OF WATER, INSTEAD OF THE 10ML AS MENTIONED ON THE PRODUCT. SO THIS SITUATION IS CONSIDERED AS A MISUSE. CHECKING THE QUALITY DATABASES REVEALED NO ANOMALY IN RELATION TO THE DESCRIBED DEFECT. A RMF EVALUATION WAS PERFORMED BASED ON CRIQ247, RISK IDENTIFIED 12606 (HAZARDOUS SITUATION: CATHETER BALLOON CANNOT BE DEFLATED (OR WITH DIFFICULTY). THE EVALUATION HAS SHOWN THAT RISKS ARE ADEQUATELY CONTROLLED AND REDUCED AS FAR AS POSSIBLE IN THE STATE OF ART LEVEL (EXCEPT RISK 11500). BASED ON THIS, WE CAN CONCLUDE THAT RESIDUAL RISKS EXCEPT FOR RISK 11500 ARE ADEQUATELY CONTROLLED AND REDUCED AS FAR AS POSSIBLE, AND THE RESIDUAL RISKS ASSOCIATED WITH THE USE OF THE PRODUCT ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS TO THE PATIENT/USER. IT IS CONCLUDED THAT THE RISKS IDENTIFIED ARE STILL ACCEPTABLE AND CONSIDERED AS SAFE. A SIMILAR CASE STUDY WAS PERFORMED ON FOLYSIL SILICONE CATHETER, ON SAME DEFECT "BALLOON INFLATION DIFFICULT/IMPOSSIBLE" FROM JANUARY 2021 TO JANUARY 2025: 55 SIMILAR CASES WERE FOUND.
THE INVESTIGATION IS NOT YET COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED ON COMPLETION OF THE INVESTIGATION. CORRECTION: A2: UPDATED WITH THE PATIENT'S AGE.
ACCORDING TO THE AVAILABLE INFORMATION, BALLOON WAS NOT ABLE TO BE EMPTIED WITH 20CC SYRINGES. BALLOON REMAINED IN PLACE FOR ABOUT 10 HOURS AND NEEDED TO BE REMOVED UNDER ULTRASOUND IN THE CONSULTING ROOM OVER A 2-HOUR PERIOD WITH SUBSEQUENT ANTIBIOTIC PROPHYLAXIS.
ACCORDING TO THE AVAILABLE INFORMATION, BALLOON WAS NOT ABLE TO BE EMPTIED WITH 20CC SYRINGES. BALLOON REMAINED IN PLACE FOR ABOUT 10 HOURS AND NEEDED TO BE REMOVED UNDER ULTRASOUND IN THE CONSULTING ROOM OVER A 2-HOUR PERIOD WITH SUBSEQUENT ANTIBIOTIC PROPHYLAXIS.
ACCORDING TO THE AVAILABLE INFORMATION, BALLOON WAS NOT ABLE TO BE EMPTIED WITH 20CC SYRINGES. BALLOON REMAINED IN PLACE FOR ABOUT 10 HOURS AND NEEDED TO BE REMOVED UNDER ULTRASOUND IN THE CONSULTING ROOM OVER A 2-HOUR PERIOD WITH SUBSEQUENT ANTIBIOTIC PROPHYLAXIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1268910 | FOLYSIL SILICONE CATHETER | INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL | EZL | COLOPLAST A/S | 03600040127230 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Unknown | Required Intervention |