BEUDAMED
    FDA Adverse Event Injury Summary report: N

    21 G X .75 IN. BD VACUTAINER® WINGED SAFETY PBBCS WITH 12 IN. TUBING

    MDR report key: 6194210 · Received December 21, 2016

    Report

    Report Number
    1710034-2016-00074
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    December 8, 2016
    Report Date
    February 25, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    JKA
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHLEBOTOMIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RESULT - A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 6281529. THERE WERE NO RELATED REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. THIS LOT WAS BUILT FROM OCTOBER 14, 2016 THRU OCTOBER 17, 2016. CONCLUSION - BD WAS UNABLE TO CONFIRM THE CUSTOMER INDICATED FAILURE MODE. WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: IT IS UNKNOWN IF A SAMPLE WILL BE RETURNED FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHLEBOTOMIST COMPLETED THE BLOOD DRAW WITH THE SUSPECT DEVICE AND PUSHED THE BUTTON TO RETRACT THE NEEDLE. THE NEEDLE DID NOT RETRACT ALL THE WAY INTO THE HUB AND SHE SCRAPED HER RIGHT FOREFINGER ON THE EXPOSED NEEDLE. THE PHLEBOTOMIST WAS SENT TO EMPLOYEE HEALTH FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843841 21 G X .75 IN. BD VACUTAINER® WINGED SAFETY PBBCS WITH 12 IN. TUBING BLOOD COLLECTION SET JKA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6281529

    Patients

    Seq Age Sex Outcome Treatment
    1 Other