BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 7063924 · Received November 28, 2017

    Report

    Report Number
    1024879-2017-00491
    Event Type
    Malfunction
    Date Received
    November 28, 2017
    Date of Event
    May 6, 2016
    Report Date
    October 26, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673426
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS NOT RETURNED FOR EVALUATION. PHOTOS OF THE RETURNED CUSTOMER SAMPLE SHOWS EVIDENCE OF SEPARATION OF THE FRONT AND REAR BARREL. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6042544. 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. BD HAS INITIATED CAPA (B)(4) TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE(S) OF THIS PRODUCT ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY MECHANISM ON THE 23 G X .75 IN BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET WITH 12 IN TUBING AND LUER ADAPTER BROKE APART WHEN TRYING TO ACTIVATE. BLOOD SPLATTER DID OCCUR BUT THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841693 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD COLLECTION SET JKA BECTON, DICKINSON & CO., (BD) 6042544 50382903673426

    Patients

    Seq Age Sex Outcome Treatment
    1 Other