FOLEY CATHETER, 400 SERIES 16 FR
Report
- Report Number
- 2320762-2022-00014
- Event Type
- Malfunction
- Date Received
- August 7, 2024
- Date of Event
- November 23, 2022
- Report Date
- November 25, 2024
- Manufacturer
- DEROYAL INDUSTRIES, INC.
- Product Code
- EYC
- UDI-DI
- 00749756045766
- PMA / PMN Number
- K200757
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A USER FACILITY COMPLAINT WAS RECEIVED ON 11/23/2022 REPORTING, "CATHETER DISLODGED UPON SURGICAL DRAPE REMOVAL. BALLOON INFLATION PERFORMED WHICH DEMONSTRATED PINHOLE LEAKAGE IN BALLOON, WHICH SUBSEQUENTLY BURST." A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN SENT TO THE FOLEY CATHETER SUPPLIER, XERIDIEM MEDICAL DEVICES. THE SAMPLE HAS BEEN REQUESTED FOR RETURN BUT HAS NOT YET BEEN RETURNED TO DEROYAL FOR EVALUATION AT THIS TIME. 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 BECOMES AVAILABLE.
THE FOLEY CATHETER WAS RECEIVED BY DEROYAL ON 01/09/2023, BUT IT WAS NOTED THAT THE SAMPLE WAS NOT RETURNED WITHIN THE STATED TIMEFRAME ALLOTTED FOR INVESTIGATION AND WAS UNABLE TO BE TESTED BY VENDOR DURING INVESTIGATION. SAMPLE WILL BE SENT TO SUPPLIER FOR ADDITIONAL TESTING. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN SENT TO THE FOLEY CATHETER SUPPLIER, XERIDIEM MEDICAL DEVICES. ROOT CAUSE: IT WAS DETERMINED TO BE UNKNOWN BY THE SUPPLIER XERIDIEM MEDICAL DEVICES AS WITHOUT MORE INFORMATION, THE DEFECT COULD NOT BE REPRODUCED OR CONFIRMED. POTENTIAL ROOT CAUSE COULD ALSO NOT BE DETERMINED BY XERIDIEM MEDICAL DEVICES. THEY STATED THAT BECAUSE THE DEVICE WAS IN USE WHEN THE DEFECT WAS OBSERVED, THIS INCIDENT IS NOT CONSIDERED AN OUT OF BOX FAILURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED TO CONFIRM WHERE THE MALFUNCTION COULD HAVE EVOLVED SUCH AS, HOW LONG THE DEVICE WAS USED ON THE PATIENT, WAS THERE PATIENT UNDERLYING CONDITIONS THAT CONTRIBUTED TO BALLOON FAILURE, WAS THE DEVICE TESTED PRIOR TO USE, WAS THERE MISHANDLING OR ENVIRONMENTAL CONDITIONS THAT APPLY, ETC. WITHOUT HAVING MORE DETAILS, THE ROOT CAUSE CANNOT BE CONFIRMED. WHILE NO CORRECTIVE ACTIONS WERE TAKEN BY XERIDIEM MEDICAL DEVICES, THE FOLLOWING MANUFACTURING CONTROLS ARE USED AS PREVENTATIVE ACTIONS: DURING THE MANUFACTURING PROCESS PER THE PART SPECIFICATIONS, 100% OF THE UNITS REQUIRE MULTIPLE INSPECTIONS THROUGHOUT THE PROCESS INCLUDING 100% FLOW AND LEAK TESTING TO ALL PORTS (SENSOR LUMEN, BALLOON INFLATION LUMEN, AND SHAFT/FUNNEL) AND BALLOON INFLATIONS FOR A MINIMUM DURATION FOR PRODUCT INTEGRITY. THESE VERIFICATIONS WILL DETECT FAILURE MODES WHERE DEFECTIVE PRODUCT WILL BE SEGREGATED AND SCRAPPED ACCORDINGLY. CURRENT SPG (XERIDIEM) CONTROLS INCLUDE TRAINING AND CERTIFICATION OF ALL PRODUCTION PERSONNEL AND QC INSPECTORS. LINE CLEARANCES ARE PERFORMED AND DOCUMENTED AT EACH WORKSTATION. ALL MOLDS, PRESSES, AND TESTING EQUIPMENT USED TO MANUFACTURE THE PRODUCT LINES ARE DOCUMENTED WITHIN DEVICE HISTORY RECORDS (DHR) AND CLEANED AND CALIBRATED WHEN APPLICABLE. CONTROLS SURROUNDING THE ACTUAL SILICONE MATERIAL INCLUDE STRINGENT STORAGE, MILLING, CLEANING, AND EXTRUSION RULES. DETAILED DHR/PIC (PICTORIAL INSTRUCTIONS) ARE PRESENT AT EACH WORKSTATION AND DELIVER SPECIFIC GUIDANCE FOR EVERY STEP OF THE MANUFACTURING PROCESS. AN INVENTORY CHECK OF THE CATHETER WAS MADE BY DEROYAL, A TOTAL OF 49 OF THE 74-12030 CATHETERS WERE INSPECTED AND NO DISCREPANCIES WERE IDENTIFIED DURING INSPECTION. A COMPLAINT TO SALES RATIO WAS ALSO CONDUCTED BY DEROYAL FINDING THAT FROM NOVEMBER 2021 TO PRESENT DAY (B)(4) UNITS OF PRODUCT NUMBER 81-080416 HAVE BEEN SOLD AND WITHIN THAT REVIEW PERIOD ONLY ONE TOTAL COMPLAINT HAS BEEN RECEIVED FOR THIS PRODUCT. THIS EQUATES TO A COMPLAINT RATIO OF (B)(4). BOTH DEROYAL AND XERIDIEM MEDICAL DEVICES WILL CONTINUE TO MONITOR FOR TRENDS RELATING TO THIS PRODUCT AND ISSUE. 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 11/23/2022 REPORTING, "CATHETER DISLODGED UPON SURGICAL DRAPE REMOVAL. BALLOON INFLATION PERFORMED WHICH DEMONSTRATED PINHOLE LEAKAGE IN BALLOON, WHICH SUBSEQUENTLY BURST." A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN SENT TO THE FOLEY CATHETER SUPPLIER, (B)(4). THE SAMPLE HAS BEEN REQUESTED FOR RETURN BUT HAS NOT YET BEEN RETURNED TO DEROYAL FOR EVALUATION AT THIS TIME. 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 BECOMES AVAILABLE.
CATHETER DISLODGED UPON SURGICAL DRAPE REMOVAL. BALLOON INFLATION PERFORMED WHICH DEMONSTRATED PINHOLE LEAKAGE IN BALLOON, WHICH SUBSEQUENTLY BURST.
CATHETER DISLODGED UPON SURGICAL DRAPE REMOVAL. BALLOON INFLATION PERFORMED WHICH DEMONSTRATED PINHOLE LEAKAGE IN BALLOON, WHICH SUBSEQUENTLY BURST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 580847 | FOLEY CATHETER, 400 SERIES 16 FR | CATHETER, UPPER URINARY TRACT | EYC | DEROYAL INDUSTRIES, INC. | 81-080416 | 00749756045766 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |