FOLEY CATHETER, 400 SERIES 8 FR
Report
- Report Number
- 2320762-2023-00003
- Event Type
- Malfunction
- Date Received
- August 7, 2024
- Date of Event
- March 27, 2023
- Report Date
- November 25, 2024
- Manufacturer
- DEROYAL INDUSTRIES, INC.
- Product Code
- EYC
- PMA / PMN Number
- K041416
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 003
Narratives
A USER FACILITY REPORTED ON 3/27/2023, THAT "POST OP CARDIAC PATIENT FOLEY WITH TEMP PROBE INSERTED IN OR. LESS THAN 12 HOURS AFTER INSERTION, FUNCTIONED ONLY TRANSIENTLY THEN STOPPED ON SECOND DAY. HAPPENED WITH ANOTHER PATIENT 2 DAYS LATER, ALSO POST OP CARDIAC PATIENT. FOLEY COULD NOT BE REMOVED AS RISK THAT IT COULDN'T BE REINSERTED SO RECTAL PROBE WAS USED. NOT BEST PRACTICE ON BABIES." PRODUCT HAS BEEN REQUESTED FOR RETURN TO DEROYAL, BUT IT IS UNKNOWN AT THIS TIME IF IT WILL BE ABLE TO BE RETURNED. 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.
A USER FACILITY REPORTED ON 3/27/2023, THAT "POST OP CARDIAC PATIENT FOLEY WITH TEMP PROBE INSERTED IN OR. LESS THAN 12 HOURS AFTER INSERTION, FUNCTIONED ONLY TRANSIENTLY THEN STOPPED ON SECOND DAY. HAPPENED WITH ANOTHER PATIENT 2 DAYS LATER, ALSO POST OP CARDIAC PATIENT. FOLEY COULD NOT BE REMOVED AS RISK THAT IT COULDN'T BE REINSERTED SO RECTAL PROBE WAS USED. NOT BEST PRACTICE ON BABIES." PRODUCT HAS BEEN REQUESTED FOR RETURN TO DEROYAL, BUT IT IS UNKNOWN AT THIS TIME IF IT WILL BE ABLE TO BE RETURNED. 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.
NO SAMPLE OR PICTURES OF SAMPLE WERE RETURNED TO DEROYAL INDUSTRIES. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE CATHETER SUPPLIER SPG/XERIDIEM MEDICAL DEVICES. XERIDIEM CONDUCTED TRENDING AND CONCLUDED THAT THERE WAS A VERY LOW OCCURRENCE RATE. THEY ALSO REVIEWED VERIFICATION TESTING AS WELL AS TRAINING FOR QUALITY CONTROL INSPECTORS AND FOUND NO ISSUES. ROOT CAUSE: WAS NOT ABLE TO BE DETERMINED BY SPG/XERIDIEM MEDICAL DEVICES AS NOT ENOUGH INFORMATION OR SAMPLE DEVICES WERE ABLE TO BE PROVIDED. POTENTIAL ROOT CAUSE DETERMINED BY SPG/XERIDIEM MEDICAL DEVICES: IT WAS DETERMINED THAT WAS NOT CONSIDERED AN OUT OF BOX FAILURE. WHEN THE DEVICE HAS BEEN IN USE, IT'S SUBJECT TO OTHER FACTORS THAT MAY CONTRIBUTE TO DEVICE FAILURES OR AFFECT PRODUCT PERFORMANCE SUCH AS DIAGNOSIS AND TREATMENT, DEVICE HANDLING, ENVIRONMENT, PACKAGING, SHIPPING, STORAGE, CLEANING, AND MAINTENANCE. THESE CONDITIONS CAN INDUCE DEVICE MALFUNCTIONS. DEROYAL ALSO REVIEWED THE FAILURE MODES AND EFFECTS ANALYSIS (FMEA) AND INVENTORY IN FACILITY. 15 CASES OF THE CATHETERS WERE ABLE TO BE REVIEWED. THE FMEA NOR INVENTORY HAD ANY ISSUES. (B)(4). WITHIN THAT SAME TIME FRAME, 3 COMPLAINTS WERE RECEIVED FOR THIS PRODUCT LEADING TO A RATIO OF (B)(4). DEROYAL WILL CONTINUE TO MONITOR TRENDS SURROUND THIS ISSUE AND PRODUCT. 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.
POST OP CARDIAC PATIENT FOLEY WITH TEMP PROBE INSERTED IN OR. LESS THAN 12 HOURS AFTER INSERTION, FUNCTIONED ONLY TRANSIENTLY THEN STOPPED ON SECOND DAY. HAPPENED WITH ANOTHER PATIENT 2 DAYS LATER, ALSO POST OP CARDIAC PATIENT. FOLEY COULD NOT BE REMOVED AS RISK THAT IT COULDN'T BE REINSERTED SO RECTAL PROBE WAS USED. NOT BEST PRACTICE ON BABIES.
POST OP CARDIAC PATIENT FOLEY WITH TEMP PROBE INSERTED IN OR. LESS THAN 12 HOURS AFTER INSERTION, FUNCTIONED ONLY TRANSIENTLY THEN STOPPED ON SECOND DAY. HAPPENED WITH ANOTHER PATIENT 2 DAYS LATER, ALSO POST OP CARDIAC PATIENT. FOLEY COULD NOT BE REMOVED AS RISK THAT IT COULDN'T BE REINSERTED SO RECTAL PROBE WAS USED. NOT BEST PRACTICE ON BABIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 560555 | FOLEY CATHETER, 400 SERIES 8 FR | CATHETER, UPPER URINARY TRACT | EYC | DEROYAL INDUSTRIES, INC. | 81-080408 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |