BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR P50

    MDR report key: 7974038 · Received October 17, 2018

    Report

    Report Number
    3003152976-2018-00437
    Event Type
    Malfunction
    Date Received
    October 17, 2018
    Date of Event
    September 25, 2018
    Report Date
    November 7, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905151058
    PMA / PMN Number
    K123213
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE PICTURE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. UPON INSPECTION OF THE PICTURE SAMPLE, THE NEEDLE WAS OBSERVED SEPARATED FROM THE PROTECTOR PRODUCT. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER (1802130) THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. TWO RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR FURTHER INVESTIGATION. BOTH OF THE RETAINED SAMPLES FIT THE VIAL PROPERLY AND SUPPORTED THE WEIGHT OF THE VIAL (190 GRAMS) WHEN LIFTED. BASED ON THE INVESTIGATION, IT WAS DETERMINED THAT THE PROTECTOR PRODUCT CAN SUPPORT THE WEIGHT OF THE VIAL. PLEASE NOTE THAT THE PROTECTORS ARE NOT INTENDED TO BE REMOVED FROM THE VIALS. DURING THE REMOVAL, THE NEEDLES MAY BECOME DETACHED. TO ENSURE PROPER ATTACHMENT OF THE PROTECTOR, USE OF THE M12 ASSEMBLY FIXTURE IS RECOMMENDED. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD PHASEAL¿ PROTECTOR P50 THERE WAS AN ISSUE WITH THE PROTECTOR COMING OFF OF THE VIAL LEAVING ONLY THE NEEDLE IN THE VIAL. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD PHASEAL¿ PROTECTOR P50 THERE WAS AN ISSUE WITH THE PROTECTOR COMING OFF OF THE VIAL LEAVING ONLY THE NEEDLE IN THE VIAL. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817036 BD PHASEAL¿ PROTECTOR P50 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1802130 30382905151058

    Patients

    Seq Age Sex Outcome Treatment
    1 Other