BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT GLASS MOLECULAR DIAGNOSTICS TUBE

    MDR report key: 7058841 · Received November 27, 2017

    Report

    Report Number
    1917413-2017-00355
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    February 21, 2016
    Report Date
    November 8, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JCF
    UDI-DI
    00382903627530
    PMA / PMN Number
    K891407
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. RESULT: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR BREAKAGE WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT # 5105880 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 16X125 MM., 8.0 ML. BD VACUTAINER® CPT GLASS MOLECULAR DIAGNOSTICS TUBE. GREEN/RED CONVENTIONAL CLOSURE. SEE THRU LABEL. ADDITIVE: DENSITY GRADIENT POLYMER GEL AND SODIUM HEPARIN FOR MONONUCLEAR CELL PREPARATION, BROKE DURING CENTRIFUGATION. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840854 BD VACUTAINER® CPT GLASS MOLECULAR DIAGNOSTICS TUBE CELL PREP TUBE JCF BECTON, DICKINSON & CO. 5105880 00382903627530

    Patients

    Seq Age Sex Outcome Treatment
    1 Other