BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® GLASS CITRATETUBES WITH A LT. BLUE BD HEMOGARD¿

    MDR report key: 7058954 · Received November 27, 2017

    Report

    Report Number
    9617032-2017-00219
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    April 25, 2016
    Report Date
    November 13, 2017
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE FOR BREAKAGE WAS NOT OBSERVED AS ALL SAMPLES MET SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT #5132225 AND NO ISSUES WERE IDENTIFIED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A GLASS BD VACUTAINER® CITRATE TUBES WITH A LT. BLUE BD HEMOGARD¿ CLOSURE BROKE AS IT WAS INSERTED INTO THE HOLDER. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840812 BD VACUTAINER® GLASS CITRATETUBES WITH A LT. BLUE BD HEMOGARD¿ CITRATE SERUM TUBES JKA BECTON, DICKINSON AND COMPANY (BD) 5132225

    Patients

    Seq Age Sex Outcome Treatment
    1 Other