BD PHASEAL¿ PROTECTOR (P14)
Report
- Report Number
- 3003152976-2022-00055
- Event Type
- Malfunction
- Date Received
- February 9, 2022
- Date of Event
- January 26, 2022
- Report Date
- April 14, 2022
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- ONB
- UDI-DI
- 30382905151003
- PMA / PMN Number
- K123213
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES. D9: RETURNED TO MANUFACTURER ON: 14-APR-2022. H6: INVESTIGATION SUMMARY: TWO PROTECTORS WERE RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, NO DEFECTS ON THE PRODUCT OR ISSUES RELATED TO THE CONNECTION OF THE PROTECTOR TO THE VIAL WERE OBSERVED. FUNCTIONAL EVALUATIONS WERE CONDUCTED, CONNECTING AN INJECTOR AND SYRINGE TO THE PROTECTORS. LIQUID COULD MOVE FROM THE VIAL TO THE SYRINGE AND BACK WITHOUT ISSUE AND NO LEAKAGES WERE OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2001137, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THESE ISSUES. FIVE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS INSPECTED, NO DAMAGE OR DEFECTS WERE NOTED, ALL PROTECTOR NEEDLES WERE VERIFIED TO BE SECURELY ATTACHED TO THE DEVICE. FUNCTIONAL TESTING WAS PERFORMED, IN ALL CASES THE PRODUCT FUNCTIONED AS INTENDED AND NO LEAKAGES OCCURRED. PRODUCT UNDERGOES A SERIES OF TESTING DURING MANUFACTURING TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. THESE TESTS INCLUDE VISUAL INSPECTIONS ALONG WITH LEAKAGE TESTING, ALL RECORDS WERE REVIEWED FOR THE REPORTED LOT AND RESULTS WERE FOUND TO BE ACCEPTABLE. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 2 BD PHASEAL¿ PROTECTORS (P14) LEAKED WHEN ATTACHED TO MEDICATION VIALS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD SEVERAL ISSUES WITH BD PHASEAL PROTECTOR (P14) RECENTLY. WE HAVE FOUND WHEN ATTACHED TO A VIAL THEY ARE LEAKING. MOST RECENTLY YESTERDAY WHEN ATTACHED TO AN ETOPOSIDE VIAL."
IT WAS REPORTED THAT 2 BD PHASEAL¿ PROTECTORS (P14) LEAKED WHEN ATTACHED TO MEDICATION VIALS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD SEVERAL ISSUES WITH BD PHASEAL PROTECTOR (P14) RECENTLY. WE HAVE FOUND WHEN ATTACHED TO A VIAL THEY ARE LEAKING. MOST RECENTLY YESTERDAY WHEN ATTACHED TO AN ETOPOSIDE VIAL."
IT WAS REPORTED THAT 2 BD PHASEAL¿ PROTECTORS (P14) LEAKED WHEN ATTACHED TO MEDICATION VIALS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD SEVERAL ISSUES WITH BD PHASEAL PROTECTOR (P14) RECENTLY. WE HAVE FOUND WHEN ATTACHED TO A VIAL THEY ARE LEAKING. MOST RECENTLY YESTERDAY WHEN ATTACHED TO AN ETOPOSIDE VIAL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1086228 | BD PHASEAL¿ PROTECTOR (P14) | INTRAVASCULAR ADMINISTRATION SET | ONB | BECTON DICKINSON, S.A. | 515100 | 2001137 | 30382905151003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |