BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLASMA PREPARATION TUBE PPT¿

    MDR report key: 7075927 · Received December 1, 2017

    Report

    Report Number
    1917413-2017-00504
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    March 7, 2017
    Report Date
    November 14, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JCF
    UDI-DI
    00382903627615
    PMA / PMN Number
    K911731
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR MISSING LABEL WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. CONCLUSION: AFTER INVESTIGATION, THERE WERE NO MANUFACTURING RELATED NOTIFICATIONS THAT WOULD ACCOUNT FOR THIS DEFECT. THE EXACT ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® PLASMA PREPARATION TUBE (PPT¿) WAS MISSING A LABEL. NO SERIOUS INJURY, NO MEDICAL INTERVENTIONS. PROBLEM WAS NOTICED BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853672 BD VACUTAINER® PLASMA PREPARATION TUBE PPT¿ BLOOD COLLECTION TUBE JCF BECTON, DICKINSON & CO. 6245977 00382903627615

    Patients

    Seq Age Sex Outcome Treatment
    1 Other