FOLEY CATHETER, 400 SERIES 16 FR (+/-0.1C)
Report
- Report Number
- 2320762-2023-00005
- Event Type
- Injury
- Date Received
- August 7, 2024
- Date of Event
- April 28, 2023
- Report Date
- November 25, 2024
- Manufacturer
- DEROYAL INDUSTRIES, INC.
- Product Code
- EYC
- UDI-DI
- 00749756596664
- PMA / PMN Number
- K200757
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- 003
Narratives
REPORTER SUBMITTED THE FOLLOWING: "THE CATHETERS CLOGGED EVERY TIME WHERE THE PATIENT GETS A PROPER BLADDER RETENTION WITH ALL ITS CONSEQUENCES. IT SEEMS THAT THIS IS RELATED TO THE BALLOON CHANGE." THIS REPORT CAME IN AS ONE COMPLAINT, BUT BECAUSE IT DESCRIBED NINE SEPARATE EVENTS, IT WILL BE REPORTED FOR EACH EVENT. THIS REPORT IS TWO OF NINE (2/9). A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE FOLEY CATHETER SUPPLIER XERIDIEM MEDICAL DEVICES. IN REFERENCE TO "BALLOON CHANGE", THERE HAS BEEN NO DESIGN CHANGE TO WHAT IS CURRENTLY IN THE FIELD. INVESTIGATION IS UNDERWAY TO DETERMINE THE NATURE OF THIS COMMENT AS WELL AS THE ROOT CAUSE OF THE ISSUE. 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.
THE SAMPLE WAS DISCARDED SO NO SAMPLES WERE AVAILABLE FOR RETURN TO DEROYAL INDUSTRIES. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE FOLEY CATHETER SUPPLIER XERIDIEM MEDICAL DEVICES. THIS REPORT CAME IN AS ONE COMPLAINT, BUT BECAUSE IT DESCRIBED NINE SEPARATE EVENTS, IT WILL BE REPORTED FOR EACH EVENT. THIS REPORT IS TWO OF NINE (2/9). IT WAS DETERMINED THAT THESE COMPLAINTS TOOK PLACE OVER THE SPAN OF 12 MONTHS. WITH THAT, IN REFERENCE TO THE "BALLOON CHANGE," THERE HAS BEEN NO CHANGE TO THE CATHETERS PROVIDED BY XERIDIEM. XERIDIEM DOES NOT CONSIDER THIS ISSUE TO BE AN OUT OF BOX FAILURE. THE DEVICE WAS FUNCTIONAL PRIOR TO PATIENT APPLICATION AND OBSERVED AS LATENT FAILURES FROM USE. DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE WITHIN SPECIFICATION. XERIDIEM ALSO REVIEWED RISK DOCUMENTATION AND ANY OPEN CORRECTIVE ACTION AND PREVENTIVE ACTION (CAPA) POINTS, NO CAPAS OR NEW RISK INFORMATION WAS IDENTIFIED. A COMPLIANT RECORD REVIEW WAS COMPLETED BY XERIDIEM, BETWEEN MAY 2022 AND JUNE 2023, OVER (B)(4) UNITS WERE SOLD AND THERE WERE 27 DEVICE DEFECTS FOR PLUGGED LUMEN. ROOT CAUSE: WAS UNABLE TO BE CONFIRMED BY THE SUPPLIER XERIDIEM MEDICAL DEVICES. POTENTIAL ROOT CAUSE: BECAUSE THESE COMPLAINTS WERE NOT CONSIDERED TO BE OUT OF BOX FAILURES, THERE ARE OTHER FACTORS OR POSSIBILITIES THAT MAY HAVE INDUCED DEVICE MALFUNCTIONS. THESE FACTORS CAN INCLUDE DIAGNOSIS AND TREATMENT, DEVICE HANDLING, ENVIRONMENT, STORAGE, CLEANING, MAINTENANCE, PATIENT CONDITIONS, AND OTHER ELEMENTS THAT ARE OUT OF XERIDIEM'S CONTROL. EACH OF THESE CONDITIONS COULD POTENTIALLY INDUCE DEVICE MALFUNCTIONS; HOWEVER, THESE DEVICES ARE NOT PERMANENT AND SHALL BE CARED FOR AND REPLACED AS NEEDED OR REQUIRED. CORRECTIVE AND PREVENTIVE ACTIONS: BECAUSE XERIDIEM COULD NOT CONFIRM THE ISSUE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN. DEROYAL INDUSTRIES ALSO CONDUCTED AN INVESTIGATION. SPECIFICATIONS, WORK ORDERS, AND INVENTORY CHECKS WERE CONDUCTED AND NO ISSUES WERE FOUND. LABELING, CAPAS, AND FAILURE MODES AND EFFECTS ANALYSIS (FMEA)'S WERE ALSO REVIEWED, WITH NO ISSUES OR MISSING INFORMATION FOUND. DEROYAL ALSO CREATED A COMPLAINT TO SALES RATIO: BETWEEN MAY 2022 AND JUNE 2023, DEROYAL HAS SOLD 374 UNITS (18,700 INDIVIDUAL FOLEYS) OF ITEM 81-080416EU. DURING THAT SAME TIME FRAME, A TOTAL OF 9 COMPLAINTS WERE RECEIVED FOR THIS PRODUCT. THIS EQUATES TO A COMPLAINT RATIO OF 0.00481 OR 0.0481%. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUES. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF MORE INFORMATION WILL BECOME AVAILABLE.
REPORTER SUBMITTED THE FOLLOWING: "THE CATHETERS CLOGGED EVERY TIME WHERE THE PATIENT GETS A PROPER BLADDER RETENTION WITH ALL ITS CONSEQUENCES. IT SEEMS THAT THIS IS RELATED TO THE BALLOON CHANGE." THIS REPORT CAME IN AS ONE COMPLAINT, BUT BECAUSE IT DESCRIBED NINE SEPARATE EVENTS, IT WILL BE REPORTED FOR EACH EVENT. THIS REPORT IS TWO OF NINE (2/9). A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE FOLEY CATHETER SUPPLIER XERIDIEM MEDICAL DEVICES. IN REFERENCE TO "BALLOON CHANGE", THERE HAS BEEN NO DESIGN CHANGE TO WHAT IS CURRENTLY IN THE FIELD. INVESTIGATION IS UNDERWAY TO DETERMINE THE NATURE OF THIS COMMENT AS WELL AS THE ROOT CAUSE OF THE ISSUE. 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.
THE CATHETERS CLOGGED EVERY TIME WHERE THE PATIENT GETS A PROPER BLADDER RETENTION WITH ALL ITS CONSEQUENCES. IT SEEMS THAT THIS IS RELATED TO THE BALLOON CHANGE.
THE CATHETERS CLOGGED EVERY TIME WHERE THE PATIENT GETS A PROPER BLADDER RETENTION WITH ALL ITS CONSEQUENCES. IT SEEMS THAT THIS IS RELATED TO THE BALLOON CHANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 560546 | FOLEY CATHETER, 400 SERIES 16 FR (+/-0.1C) | CATHETER, UPPER URINARY TRACT | EYC | DEROYAL INDUSTRIES, INC. | 81-080416EU | 57180698 | 00749756596664 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |