FOLEY CATHETER, 400 SERIES 8 FR
Report
- Report Number
- 2320762-2022-00011
- Event Type
- Malfunction
- Date Received
- August 7, 2024
- Date of Event
- August 23, 2022
- Report Date
- November 25, 2024
- Manufacturer
- DEROYAL INDUSTRIES, INC.
- Product Code
- EYC
- UDI-DI
- 00749756045803
- PMA / PMN Number
- K041416
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 003
Narratives
A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE FOLEY CATHETER SUPPLIER (XERIDIEM). ROOT CAUSE: THE DEVICE WAS NOT RETURNED FOR EVALUATION. BESIDES THE COMPLAINT DESCRIPTION, NO ADDITIONAL EVIDENCE WAS PROVIDED SUCH AS A SAMPLE, PHOTOS, OR VIDEO; THEREFORE, A PHYSICAL OR VISUAL EVALUATION CANNOT BE CONDUCTED. WITHOUT HAVING MORE INFORMATION, THE DEFECT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED BY XERIDIEM. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE THE INVESTIGATION BY XERIDIEM WAS LIMITED TO TRENDING ONLY. TRENDING WAS PERFORMED FOR THE DEVICE FAMILY, DEFECT CODES, AND THE SPECIFIC PART NUMBER. IT RESULTED IN ONE OTHER DOCUMENTED COMPLAINT. FOR THE PREVIOUS YEAR COMPLAINTS WERE REVIEWED FOR THE DEVICE FAMILY AND SPECIFIC DEVICE IN WHICH THERE WAS ONLY 1 REPORTED COMPLAINT FOR BALLOON BURSTS/CUTS/TEARS. DEROYAL WILL NOT BE TAKING ANY CORRECTIVE ACTION AT THIS TIME, BUT WILL CONTINUE TO MONITOR FOLEY CATHETERS FOR TRENDS. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
A USER FACILITY COMPLAINT WAS RECEIVED ON 08/23/2022 REPORTING, "BURST FOLEY BALLOON, LED TO DISLODGEMENT OF INDWELLING URINARY CATHETER. LARGE HOLE NOTED IN BALLOON ON INSPECTION". A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE FOLEY CATHETER SUPPLIER XERIDIEM MEDICAL DEVICES. THE SAMPLE IS NOT AVAILABLE FOR RETURN TO DEROYAL FOR EVALUATION. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT ONCE MORE INFORMATION IS CONCLUDED FROM THE INVESTIGATION AND CORRECTIVE ACTIONS ARE DETERMINED.
A USER FACILITY COMPLAINT WAS RECEIVED ON 08/23/2022 REPORTING, "BURST FOLEY BALLOON, LED TO DISLODGEMENT OF INDWELLING URINARY CATHETER. LARGE HOLE NOTED IN BALLOON ON INSPECTION". A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE FOLEY CATHETER SUPPLIER (B)(4). THE SAMPLE IS NOT AVAILABLE FOR RETURN TO DEROYAL FOR EVALUATION. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT ONCE MORE INFORMATION IS CONCLUDED FROM THE INVESTIGATION AND CORRECTIVE ACTIONS ARE DETERMINED.
BURST FOLEY BALLOON, LED TO DISLODGEMENT OF INDWELLING URINARY CATHETER. LARGE HOLE NOTED IN BALLOON ON INSPECTION.
BURST FOLEY BALLOON, LED TO DISLODGEMENT OF INDWELLING URINARY CATHETER. LARGE HOLE NOTED IN BALLOON ON INSPECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 560320 | FOLEY CATHETER, 400 SERIES 8 FR | CATHETER, UPPER URINARY TRACT | EYC | DEROYAL INDUSTRIES, INC. | 81-080408 | 00749756045803 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |