BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR P14J

    MDR report key: 8039404 · Received November 5, 2018

    Report

    Report Number
    3003152976-2018-00475
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Date of Event
    October 16, 2018
    Report Date
    December 3, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    LHI
    UDI-DI
    00382905151095
    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: THE SAMPLE WAS EVALUATED BY JFR LAB. THE LEAK IS CONFIRMED. THE METALLIC CAP OF THE RUBBER STOPPER IS FOUND DAMAGED. LEAK BETWEEN PROTECTOR AND VIAL. THE LEAK WAS CONFIRMED. THE NEEDLE OF THE PROTECTOR DIDN¿T PUNCTURE THE CENTER OF THE RUBBER STOPPER. THE METALLIC CAP WAS FOUND DAMAGED. AS A LOT NUMBER WAS UNKNOWN FOR THIS INCIDENT, A PRODUCTION HISTORY REVIEW COULD NOT BE COMPLETED AND ADDITIONAL RETAINED SAMPLES COULD NOT BE INVESTIGATED. INSPECTIONS AND TESTS IN MANUFACTURING AREA FOR PROTECTORS: PROTECTOR HOUSING WERE MANUFACTURED BY NOLATO SUPPLIER. CURRENTLY, THEY ARE MOLDED IN BD SAN AGUSTIN PLANT. VISUAL INSPECTIONS AND CRITICAL DIMENSIONS FOR PROTECTOR HOUSING PARTS ARE PERFORMED ACCORDING TO PH-300 CURRENT VERSION. DURING ASSEMBLY PROCESS, THE OPERATOR PERFORMS THE FOLLOWING INSPECTIONS AND TESTS ACCORDING TO PH-302 CURRENT VERSION: - IT IS VERIFIED THAT EXPANSION FILM OF THE BLADDER IS CENTERED IN THE PROTECTOR HOUSING, CORRECTLY SEALED AND FREE OF HOLES OR DAMAGES. - VISUAL INSPECTION OF THE FILTER IS PERFORMED TO VERIFY THAT IS CENTERED IN THE PROTECTOR CAVITY, WELDED IN A RIGHT POSITION AND FREE OF HOLES BETWEEN THE FILTER AND FILTER COVER. - OVERPRESSURE TEST IS PERFORMED TO VERIFY THAT THE EXPANSION FILM OF THE BLADDER CAN RESIST CERTAIN PRESSURE. - FILM BREAKAGE TEST: THE EXPANSION FILM OF THE BLADDER MUST BREAK AT MINIMUM PRESSURE (0,8 BAR). IT IS VERIFY IF THE BREAK IS PRODUCED IN THE SEALING AREA OF THE FILM OR BETWEEN THE PROTECTOR AND THE FILM. - FUNCTIONALITY TEST IS PERFORMED TO ENSURE PROPERLY WORK OF THE PROTECTOR. - HYDROPHOBIC FILTER LEAKAGE IS PERFORMED TO VERIFY THAT NO LEAKS ARE PRESENT IN THE FILTER. THE DEFECT IS CAUSED DUE TO A BAD CONNECTION OF THE PROTECTOR TO THE VIAL. THE ISSUE IS NOT RELATED TO THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD PHASEAL¿ PROTECTOR P14J LEAKED DURING ASPIRATION. THE LEAKAGE OCCURRED AT THE OPENING OF THE PROTECTOR. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). 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 THAT A BD PHASEAL¿ PROTECTOR P14J LEAKED DURING ASPIRATION. THE LEAKAGE OCCURRED AT THE OPENING OF THE PROTECTOR. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876936 BD PHASEAL¿ PROTECTOR P14J PHASEAL ADMINISTRATION SET LHI BECTON DICKINSON, S.A. UNKNOWN 00382905151095

    Patients

    Seq Age Sex Outcome Treatment
    1 Other