BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR P50J

    MDR report key: 8223027 · Received January 7, 2019

    Report

    Report Number
    3003152976-2018-00582
    Event Type
    Malfunction
    Date Received
    January 7, 2019
    Date of Event
    December 17, 2018
    Report Date
    February 6, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    LHI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE SAMPLE UNIT WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH VISUAL INSPECTION OF THE SAMPLE, LEAKAGE WAS OBSERVED BETWEEN THE VIAL AND THE PROTECTOR. IT WAS DETERMINED THAT THE PROTECTOR NEEDLE WAS INCLINED. THE PROTECTOR NEEDLE DID NOT PUNCTURE THE MIDDLE OF THE RUBBER STOPPER; THE PUNCTURE WAS CLOSE TO THE METAL CAP EDGE. AS A LOT NUMBER WAS UNKNOWN FOR THIS INCIDENT, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AND ADDITIONAL RETAINED SAMPLES COULD NOT BE INVESTIGATED. IT HAS BEEN DETERMINED THAT THE LEAK RESULTED FROM THE INCLINED NEEDLE. TAKING INTO ACCOUNT THE AUTOMATIC INSPECTIONS PERFORMED DURING THE MANUFACTURING PROCESS FOR THE PROTECTOR NEEDLE, IT DOES NOT SEEM LIKELY THAT THE NEEDLE WAS ASSEMBLED INCLINED. IT IS POSSIBLE THAT THIS INCIDENT RESULTED DUE TO A POOR ATTACHMENT OF THE VIAL TO THE PROTECTOR. THE PROTECTOR MUST BE ATTACHED COMPLETELY VERTICAL TO THE VIAL. THE M12 ASSEMBLY FIXTURE IS RECOMMENDED TO EASE THE PROPER CONNECTION OF THE PROTECTOR TO THE VIAL. THE SAMPLE WAS EVALUATED BY JFR LAB. ACCORDING TO THE REPORT: LEAKAGE OF AIR WAS FOUND BETWEEN VIAL AND PROTECTOR. LEAKAGE BETWEEN VIAL AND PROTECTOR WAS FOUND WHEN THEY ARE SHAKEN. PICTURE 4 AND 7 IN THE REPORT SHOW THAT THE NEEDLE OF PROTECTOR IS INCLINED. PICTURE 12 CONFIRMS THAT THE NEEDLE OF THE PROTECTOR DID NOT PUNCTURE THE RUBBER. STOPPER IN THE MIDDLE, BUT CLOSE TO THE METALLIC CAP. THE POSSIBLE ROOT CAUSE OF THE DEFECT IS A BAD ATTACHMENT OF THE PROTECTOR TO THE VIAL. PROTECTOR MUST BE ATTACHED COMPLETELY VERTICALLY TO THE VIAL. THE DEFECT SEEMS TO BE CAUSED BY THE USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD PHASEAL¿ PROTECTOR P50J THERE WAS AN ISSUE WITH DRUG LEAKING WHEN MIXING THE VIAL AFTER DISENGAGING THE INJECTOR.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD PHASEAL¿ PROTECTOR P50J THERE WAS AN ISSUE WITH DRUG LEAKING WHEN MIXING THE VIAL AFTER DISENGAGING THE INJECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17068 BD PHASEAL¿ PROTECTOR P50J PHASEAL ADMINISTRATION SET LHI BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other