BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR P50J

    MDR report key: 7130869 · Received December 19, 2017

    Report

    Report Number
    3003152976-2017-00187
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    December 1, 2017
    Report Date
    February 22, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    LHI
    PMA / PMN Number
    K022426
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURING: CHANGED/CORRECTED FROM 12/01/2107 TO 12/01/2017.

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION OF THE RECEIVED SAMPLE, THE LEAK WAS VERIFIED BETWEEN THE PROTECTOR AND THE VIAL. THE CANNULA WAS FOUND BENT AND AFTER IT WAS RECONNECTED, NO LEAK WAS FOUND BETWEEN THE PROTECTOR AND THE VIAL. A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS THE LOT NUMBER IS UNKNOWN. SEVERAL TESTS AND INSPECTIONS ARE CARRIED OUT TO AVOID FAULTY PARTS DURING THE MANUFACTURING PROCESS. AMONG THEM, FUNCTIONALITY TESTING ON THE PROTECTOR IS PERFORMED. IN ORDER TO CONFIRM THAT BENT CANNULAS ARE DISCARDED BY THE ASSEMBLY MACHINE, A TEST WAS PERFORMED BY TAKING A NON-DEFECTIVE PROTECTOR WITH A BENT CANNULA AND INTRODUCING IT IN THE MACHINE. DURING PRODUCTION, THE MACHINE STOPPED AND DISCARDED THE AFFECTED DEVICE. BASED UPON THIS INVESTIGATION AND SAMPLE RECEIVED, THE ROOT CAUSE OF THIS INCIDENT APPEARS TO BE CAUSED BY THE CUSTOMER. TAKING INTO ACCOUNT THE INFORMATION EXPLAINED IN JFRL REPORT, IT SEEMS THAT THE ROOT CAUSE WAS AN INITIAL BAD CONNECTION BETWEEN THE PROTECTOR AND THE VIAL. BASED ON THE LOW SEVERITY AND FREQUENCY OF THE DEFECT IT WAS DETERMINED THAT NO CAPA IS REQUIRED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE OF THE BD PHASEAL¿ PROTECTOR P50J WHEN PREPARING CARBOPLATIN (CHEMO), THE DEVICE LEAKED FROM AN OPENING OF THE PROTECTA AND THE VIAL. THE SALES REP REPORTED NO HEALTH HAZARD. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910528 BD PHASEAL¿ PROTECTOR P50J FLUID TRANSFER IV SET LHI BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other