BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR P14J

    MDR report key: 8151151 · Received December 11, 2018

    Report

    Report Number
    3003152976-2018-00520
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Date of Event
    November 20, 2018
    Report Date
    January 14, 2019
    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: A DEVICE HISTORY RECORD WAS PERFORMED FOR THE PROVIDED LOT NUMBER (1710122) AND THE REVIEW DID NOT REVEAL ANY QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. THREE SAMPLES WERE EVALUATED BY JFR LAB. ACCORDING TO THE REPORT, LEAK BETWEEN THE PROTECTOR AND THE VIAL WAS FOUND. FIVE RETAINED SAMPLES WERE TAKEN FOR INVESTIGATION. FUNCTIONAL TEST WAS PERFORMED ON TWO RETAINED SAMPLES. NO LEAK WAS FOUND BETWEEN THE PROTECTOR AND THE VIAL. LEAK TEST WAS PERFORMED ON THREE SAMPLES: NO LEAK FOUND. LEAK BETWEEN PROTECTOR AND VIAL. 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 OR AT 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. CONCLUSION: ACCORDING TO JFRL REPORT, LEAK BETWEEN THE PROTECTOR AND THE VIALS WAS FOUND IN ONE OF THE SAMPLES. NO LEAK BETWEEN THE PROTECTOR AND THE VIAL WAS FOUND IN RETAINED SAMPLES. NO LEAK TROUGH PHASEAL MEMBRANE NEITHER. NO NON-CONFORMANCES FOUND DURING DHR REVIEW. THE ROOT CAUSE CANNOT BE ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD PHASEAL¿ PROTECTOR P14J LEAKED DURING KEYTRUDA(CHEMO) PREPARATION IN THE SAFETY CABINET, IT LEAKED AND ATTACHED TO THE HANDS WITH GLOVES.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 KEYTRUDA(CHEMO) PREPARATION IN THE SAFETY CABINET, IT LEAKED AND ATTACHED TO THE HANDS WITH GLOVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989559 BD PHASEAL¿ PROTECTOR P14J PHASEAL ADMINISTRATION SET LHI BECTON DICKINSON, S.A. 1710122 00382905151095

    Patients

    Seq Age Sex Outcome Treatment
    1 Other