BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR P50J

    MDR report key: 7926097 · Received October 2, 2018

    Report

    Report Number
    3003152976-2018-00415
    Event Type
    Malfunction
    Date Received
    October 2, 2018
    Date of Event
    September 7, 2018
    Report Date
    November 5, 2018
    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

    LOT NUMBER 1802114 FOR PRODUCT (B)(4) WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY DOCUMENTED QUALITY ISSUES DURING THE PRODUCTION OF LOT NUMBER 1802114 THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. AS A SAMPLE WAS NOT PROVIDED, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPETED. TWO RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FOR FURTHER INVESTIGATION. THROUGH VISUAL INSPECTION OF THE RETAINED SAMPLES, NO DEFECTS WERE OBSERVED. THE RETAINED SAMPLES WERE FUNCTIONALLY TESTED AND THE EXPANSION CHAMBERS WERE OBSERVED TO EXPAND PROPERLY. IF THE PROTECTOR PRODUCT IS USED MORE THAN ONCE, LIQUID MAY ACCUMULATE AND OVERSATURATE THE HYDROPHOBIC FILTER. IF OVERSATURATION OCCURS, THE RESULTING PRESSURE CAN PREVENT PROPER RELEASE OF AIR TO THE EXPANSION CHAMBER. THE SAME PRESSURE PREVENTION MAY OCCUR IF LIQUID ACCUMULATES WITHIN THE INTERNAL FACE OF THE VIAL RUBBER STOPPER. BASED ON THE INVESTIGATION RESULTS, A DEFINITE CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. COMPLAINTS RECEIVED FOR THE REPORTED DEFECT AND DEVICE WILL CONTINUE TO BE MONITORED FOR EMERGING TRENDS. THIS IS THE FIRST COMPLAINT OF EXPANSION CHAMBER DOES NOT WORK FOR LOT 1802114, PRODUCT (B)(4). NO ACTIONS INDICATED AS THE DEFECT WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PHASEAL PROTECTOR P50J EXHIBITED BLADDER INFLATION FAILURE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PHASEAL¿ PROTECTOR P50J EXHIBITED BLADDER INFLATION FAILURE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768090 BD PHASEAL¿ PROTECTOR P50J CLOSED SYSTEM DRUG DELIVERY LHI BECTON DICKINSON, S.A. 1802114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other