BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES

    MDR report key: 7477832 · Received May 1, 2018

    Report

    Report Number
    1917413-2018-01206
    Event Type
    Malfunction
    Date Received
    May 1, 2018
    Date of Event
    May 25, 2017
    Report Date
    June 7, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903679213
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS CORRECTED TO INCLUDE MULTIPLE PMA / 510(K) NUMBERS. THE ORIGINAL MDR INCLUDED ONLY #K945952. THIS IS CORRECTED TO INCLUDE THE INFORMATION FOR THE ADDITIONAL PMA / 510(K) NUMBER: PMA / 510(K)#: K901449.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR 92186 WITH THE INCIDENT LOT WAS NOT OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES HAD "SAMPLE QUALITY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317742 BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6260580 50382903679213

    Patients

    Seq Age Sex Outcome Treatment
    1 Other