BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET

    MDR report key: 7454237 · Received April 24, 2018

    Report

    Report Number
    2243072-2018-00534
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Date of Event
    May 3, 2017
    Report Date
    May 3, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    JAK
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED AWARENESS DATE: 05/08/2017.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. FOR DEVICES WITHOUT 510(K) NUMBERS:PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. (B)(4). 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 X90071 WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 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® SAFETY-LOK¿ BLOOD COLLECTION SET HAD ISSUES WITH BLUNT NEEDLES AND TUBE PUSHOFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299667 BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JAK BECTON DICKINSON 16K28T1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other