BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    21 G X .75 IN BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 7077985 · Received December 3, 2017

    Report

    Report Number
    1024879-2017-00764
    Event Type
    Malfunction
    Date Received
    December 3, 2017
    Date of Event
    December 3, 2015
    Report Date
    November 1, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    00382903673384
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. INITIAL REPORTER'S PHONE #: UNKNOWN. RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A CUSTOMER PHOTO WAS RETURNED AND SHOWED THE NP NEEDLE PROTRUDING THROUGH THE BOTTOM OF THE SLEEVE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT #5120699. CONCLUSION: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PENETRATING THE PATIENT'S VEIN, BLOOD FLEW INTO THE 21 G X .75 IN BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET HOLDER WHILE NO TUBE INSERTED. THERE WAS NO SERIOUS INJURY, BLOOD EXPOSURE OR SERIOUS INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857268 21 G X .75 IN BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET BLOOD COLLECTION SET JKA BECTON, DICKINSON & CO., (BD) 5120699 00382903673384

    Patients

    Seq Age Sex Outcome Treatment
    1 Other