BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 7437661 · Received April 17, 2018

    Report

    Report Number
    1024879-2018-00436
    Event Type
    Malfunction
    Date Received
    April 17, 2018
    Date of Event
    October 14, 2016
    Report Date
    June 7, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PMA / 510(K)# IS CORRECTED TO BK050036.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: UNCONFIRMED: BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. CUSTOMER SAMPLE/PHOTO ANALYSIS: NO CUSTOMER SAMPLE/PHOTO WAS RECEIVED FOR EVALUATION. NO DEVICE WAS RETURNED FOR EVALUATION, SO THE DATE PUT IN HIS PLACE IS THE BD AWARENESS DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER FOUND OIL GEL GLOBULES INSIDE OF THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281033 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 6092563

    Patients

    Seq Age Sex Outcome Treatment
    1 Other