BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUTAINER® PLUS PLASTIC SST¿ BLOOD COLLECTION TUBES

    MDR report key: 6772989 · Received August 8, 2017

    Report

    Report Number
    1024879-2017-00112
    Event Type
    Malfunction
    Date Received
    August 8, 2017
    Date of Event
    July 11, 2017
    Report Date
    August 4, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    K023075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 7012802. 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. UDI# (B)(4).

    Description of Event or Problem · 1

    WHILE HOLDING THE TUBE THE CAP FALLS OFF OF A VACUTAINER® PLUS PLASTIC SST¿ BLOOD COLLECTION TUBES. NO MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553155 VACUTAINER® PLUS PLASTIC SST¿ BLOOD COLLECTION TUBES BLOOD COLLECTION SET JKA BECTON, DICKINSON & CO., (BD) 7012802

    Patients

    Seq Age Sex Outcome Treatment
    1 Other