BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL PROTECTOR P53J

    MDR report key: 10506514 · Received September 9, 2020

    Report

    Report Number
    3003152976-2020-00400
    Event Type
    Malfunction
    Date Received
    September 9, 2020
    Date of Event
    August 17, 2020
    Report Date
    October 13, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 8/19/2020. H.6. INVESTIGATION: ONE PROTECTOR AND VIAL WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR DEFECTS ERE OBSERVED ON THE PROTECTOR OR PROTECTOR MEMBRANE HOWEVER, IT WAS NOTED THE PROTECTOR WAS FITTED TO THE VIAL AT AN INCLINE AND THERE WAS A SMALL OPENING BETWEEN THE VIAL AND PROTECTOR. FUNCTIONAL TESTING WAS COMPLETED, LIQUID INSIDE THE SYRINGE COULD MOVE TO THE VIAL AND BACK TO THE SYRINGE WITHOUT ISSUE AND NO LEAKS WERE OBSERVED. LEAKAGE TESTING IS PERFORMED FOR ALL LOTS DURING MANUFACTURING TO ENSURE THE QUALITY OF THE MEMBRANE, AS A VALID LOT WAS NOT PROVIDED FOR THIS INCIDENT, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. WHILE WE COULD NOT REPLICATE THE REPORTED FAILURE, BASED ON THE SAMPLE EVALUATION, IT WAS DETERMINED THAT THE PROTECTOR WAS NOT PROPERLY CONNECTED TO THE VIAL WHICH RESULTED IN THE LEAK REPORTED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PHASEAL¿ PROTECTOR P53J LEAKED CHEMO. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT LEAKAGE OF CHEMO BETWEEN THE PROTECTOR AND THE VIAL. THE DRUG USED IS CISPLATIN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. MEDICAL DEVICE LOT #: THE CUSTOMER PROVIDED LOT #190115. THIS DOES NOT MATCH THE CATALOG NUMBER PROVIDED. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PHASEAL¿ PROTECTOR P53J LEAKED CHEMO. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT LEAKAGE OF CHEMO BETWEEN THE PROTECTOR AND THE VIAL. THE DRUG USED IS CISPLATIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976770 BD PHASEAL PROTECTOR P53J PROTECTOR ONB BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other