BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR P50

    MDR report key: 7956333 · Received October 11, 2018

    Report

    Report Number
    3003152976-2018-00436
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Date of Event
    September 18, 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
    PA, US
    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 VISUAL INSPECTION OF THE PICTURE, GREY FOREIGN MATTER WAS OBSERVED WITHIN THE VIAL. THE FOREIGN MATTER WITHIN THE PICTURE APPEARED TO BE PART OF THE RUBBER STOPPER. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY QUALITY ISSUES DURING THE PRODUCTION OF LOT NUMBER 1801110 THAT COULD HAVE IMPACTED THE TENDENCY FOR CORING. FOUR RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR FURTHER INVESTIGATION. ALL OF THE RETAINED SAMPLES PERFORMED PER SPECIFICATION. CORING OF THE MEMBRANE MAY RESULT FROM FRAGMENTATION, WHICH MAY OCCUR DUE TO MULTIPLE INJECTIONS OR EXCESSIVE WELDING OF THE MEMBRANE. CORING OF THE RUBBER STOPPER MAY OCCUR DUE TO RUBBER STOPPER QUALITY, THE DIMENSIONS/DESIGN OF THE NEEDLES USED, AND/OR POOR CONNECTION OF THE PROTECTOR. AS MULTIPLE FACTORS IMPACT CORING TENDENCY, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT. IT IS RECOMMENDED THAT THE M12 ASSEMBLY FIXTURE IS USED TO ENSURE PROPER CONNECTION OF THE PROTECTOR TO THE VIAL. THE FRAGMENTATION RESULTS ARE ACCEPTABLE. NO CORRECTIVE ACTIONS ARE NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD PHASEAL¿ PROTECTOR P50 THERE WAS AN ISSUE WITH FOREIGN MATTER. 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 FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796719 BD PHASEAL¿ PROTECTOR P50 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1801110 30382905151058

    Patients

    Seq Age Sex Outcome Treatment
    1 Other