BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR

    MDR report key: 7374822 · Received March 27, 2018

    Report

    Report Number
    3003152976-2018-00132
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Date of Event
    March 23, 2018
    Report Date
    April 24, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED BY FUKUSHIMA PIR LAB FOR EVALUATION. THE CUSTOMER REFERS LEAK BETWEEN THE PROTECTOR AND THE VIAL. THE SAMPLE (VIAL + PROTECTOR) WERE EVALUATED BY JFR LAB. VISUAL INSPECTIONS OF THE PROTECTOR DOES NOT SHOWS DEFECTS. VISUAL INSPECTION OF THE VIAL SHOWS THAT THE PUNCTURE WAS NOT PERFORMED IN THE CENTER OF THE RUBBER STOPPER. ONCE RE-CONNECTED TO THE PROTECTOR, NO LEAK WAS FOUND. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. INSPECTIONS AND TESTS IN MANUFACTURING AREA FOR PROTECTORS: PROTECTOR HOUSING WERE MANUFACTURED BY (B)(4) 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: IF ANY LEAK OCCURRED, IT WOULD BE NOTICED BY THE OPERATOR HYDROPHOBIC FILTER LEAKAGE IS PERFORMED TO VERIFY THAT NO LEAKS ARE PRESENT IN THE FILTER. INVESTIGATION CONCLUSION: BASED ON TEST PERFORMED AT JFRL THE LEAK WAS NOT CONFIRMED. IT SEEMS THAT THE PROTECTOR WAS NOT PROPERLY ASSEMBLED THE FIRST TIME, CAUSING THE LEAK.

    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 THAT AFTER PREPARING THE BLEOMYCIN (CHEMOTHERAPY), IT LEAKED FROM AN OPENING ON THE BD PHASEAL¿ PROTECTOR BETWEEN THE PROTECTOR AND THE VIAL. THE CUSTOMER DISCONNECTED THEM TO CONFIRM THE ROOT CAUSE.¿ NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215924 BD PHASEAL¿ PROTECTOR CLOSED DRUG DELIVERY SYSTEM ONB BECTON DICKINSON, S.A. 1704116

    Patients

    Seq Age Sex Outcome Treatment
    1 Other