BD PHASEAL¿ PROTECTOR P50J
Report
- Report Number
- 3003152976-2022-00432
- Event Type
- Malfunction
- Date Received
- September 23, 2022
- Date of Event
- August 19, 2022
- Report Date
- November 15, 2022
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- ONB
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUTION?: YES. D10: RETURNED TO MANUFACTURER ON: 28-SEP-2022 H6: INVESTIGATION SUMMARY ONE SAMPLE AND SEVERAL PICTURES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, LINT WAS OBSERVED IN THE EXPANSION BLADDER. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE SUSPECTED LOTS 2203127 AND 2203128, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. RETAINED SAMPLES OF EACH LOT WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS INSPECTED AND NO FOREIGN MATTER OR FIBERS WERE OBSERVED ON ANY OF THE PROTECTORS. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. ALL INDIVIDUALS ARE REQUIRED TO FOLLOW PROPER GOWNING PROCEDURES BEFORE ENTERING THE ROOM. MACHINES UNDERGO ROUTINE CLEANING AND MAINTENANCE, ALL BRUSHES USED TO PERFORM THESE TASKS AND THE CLOTHING USED FOR ASSOCIATES ARE FIBER FREE. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, THE ROOT CAUSE OF THIS INCIDENT IS DUE TO PERSONNEL.
THERE WERE MULTIPLE LOT NUMBERS WHICH MAY HAVE BEEN INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2203127; MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2027; DEVICE MANUFACTURE DATE: 17-JUN-2022. MEDICAL DEVICE LOT #: 2203128; MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2027; DEVICE MANUFACTURE DATE: 05-JUL-2022. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P50J EXPERIENCED FOREIGN MATTER WITHIN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: THE HCP ATTACHED THE PROTECTOR TO A VIAL AND INJECTED AIR VIA THE SYRINGE BEFORE ASPIRATING THE DRUG SOLUTION, AND THEN DISCOVERED A FOREIGN MATTER IN THE EXPANSION CHAMBER. THE DRUG USED IS FLUOROURACIL. A FM WAS FOUND IN THE EXPANSION CHAMBER (IT LOOKS LIKE A FIBER FOR CLOTHES). IT WAS DISCOVERED WHEN THE HCP INJECTED AIR BEFORE ASPIRATING THE DRUG SOLUTION. THE AIR DID NOT ENTER THE FM AREA.
IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P50J EXPERIENCED FOREIGN MATTER WITHIN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: THE HCP ATTACHED THE PROTECTOR TO A VIAL AND INJECTED AIR VIA THE SYRINGE BEFORE ASPIRATING THE DRUG SOLUTION, AND THEN DISCOVERED A FOREIGN MATTER IN THE EXPANSION CHAMBER. THE DRUG USED IS FLUOROURACIL. A FM WAS FOUND IN THE EXPANSION CHAMBER (IT LOOKS LIKE A FIBER FOR CLOTHES). IT WAS DISCOVERED WHEN THE HCP INJECTED AIR BEFORE ASPIRATING THE DRUG SOLUTION. THE AIR DID NOT ENTER THE FM AREA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 568240 | BD PHASEAL¿ PROTECTOR P50J | INTRAVASCULAR ADMINISTRATION SET | ONB | BECTON DICKINSON, S.A. | SEE H10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |