BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT GLASS MOLECULAR DIAGNOSTICS TUBE

    MDR report key: 7084403 · Received December 5, 2017

    Report

    Report Number
    1917413-2017-00434
    Event Type
    Malfunction
    Date Received
    December 5, 2017
    Date of Event
    December 21, 2016
    Report Date
    February 22, 2018
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: MEDICAL DEVICE TYPE CHANGED TO JCF.

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURER WAS REPORTED INCORRECTLY. THE CORRECT DATE RECEIVED BY MANUFACTURER IS 12/21/2016.

    Additional Manufacturer Narrative · 1

    RESULTS: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR BREAKAGE WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT #6119586 AND NO ISSUES WERE IDENTIFIED. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    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
    862932 BD VACUTAINER® CPT GLASS MOLECULAR DIAGNOSTICS TUBE CELL PREP TUBE JCF BECTON, DICKINSON & CO. 6119586 00382903627530

    Patients

    Seq Age Sex Outcome Treatment
    1 Other