FOLEY CATHETER, 400 SERIES 8 FR
Report
- Report Number
- 2320762-2023-00014
- Event Type
- Malfunction
- Date Received
- August 9, 2024
- Date of Event
- November 10, 2023
- 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
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A USER FACILITY REPORTED, "CHECKED BALLOON AND WATER EVERYWHERE AND UPON REMOVING FROM PATIENT DISCOVERED IT HAD BURST." DEROYAL INDUSTRIES HAS REQUESTED RETURN OF THE SAMPLE. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN ISSUED TO THE MANUFACTURER OF THE FOLEY, XERIDIEM MEDICAL DEVICES. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.
A SAMPLE WAS PROVIDED TO DEROYAL FOR EVALUATION. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN ISSUED TO THE MANUFACTURER OF THE FOLEY, XERIDIEM MEDICAL DEVICES. THIS REPORT CAME IN AS ONE COMPLAINT, BUT BECAUSE IT DESCRIBED FOUR SEPARATE EVENTS, IT WILL BE REPORTED FOR EACH EVENT. THIS REPORT IS ONE OF FOUR (1/4). DEROYAL INDUSTRIES EVALUATED THE SAMPLE RETURNED FROM THE SAME LOT OF THE AFFECTED DEVICE AND NO ISSUES WERE FOUND. WORK ORDERS FOR THE AFFECTED LOT AND CURRENT INVENTORY WERE REVIEWED WITH NO ISSUES IDENTIFIED. THE FAILURE MODE EFFECTS ANALYSIS (FMEA) AND CORRECTIVE ACTIONS AND PREVENTIVE ACTIONS WERE REVIEWED AND NO UPDATES WERE REQUIRED. A COMPLAINT TO SALES RATIO WAS COMPLETED FROM NOVEMBER 2022 TO PRESENT AND CALCULATED TO BE 0.00035 OR 0.0354%. THE SCAR WAS COMPLETED BY XERIDIEM MEDICAL DEVICES. RETURNED SAMPLES WERE EVALUATED AND INFLATED WITH AIR TO SPECIFICATION AND REMAINED INFLATED. ROOT CAUSE: SAMPLE EVALUATION AND CURRENT PROCESSES WERE REVIEWED AND NO ISSUES WERE FOUND. BECAUSE OF THIS, THE COMPLAINT COULD NOT BE CONFIRMED AND NO ROOT CAUSE COULD BE DETERMINED. CORRECTIVE AND PREVENTIVE ACTIONS: BECAUSE NO ROOT CAUSE WAS DETERMINED, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF INFORMATION BECOMES AVAILABLE.
A USER FACILITY REPORTED, "CHECKED BALLOON AND WATER EVERYWHERE AND UPON REMOVING FROM PATIENT DISCOVERED IT HAD BURST." DEROYAL INDUSTRIES HAS REQUESTED RETURN OF THE SAMPLE. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN ISSUED TO THE MANUFACTURER OF THE FOLEY, XERIDIEM MEDICAL DEVICES. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.
A USER FACILITY REPORTED, "CHECKED BALLOON AND WATER EVERYWHERE AND UPON REMOVING FROM PATIENT DISCOVERED IT HAD BURST."
A USER FACILITY REPORTED, "CHECKED BALLOON AND WATER EVERYWHERE AND UPON REMOVING FROM PATIENT DISCOVERED IT HAD BURST."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2462184 | FOLEY CATHETER, 400 SERIES 8 FR | CATHETER, UPPER URINARY TRACT | EYC | DEROYAL INDUSTRIES, INC. | 81-080408 | 59166435 | 00749756045803 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |