BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 7000254 · Received November 3, 2017

    Report

    Report Number
    1024879-2017-00504
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Date of Event
    July 5, 2016
    Report Date
    October 25, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    00382903673421
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED (B)(4) SAMPLES OF LOT 6131789, (B)(4) SAMPLES OF LOT 6130960 AND (B)(4) SAMPLES OF LOT 6153651 FROM CUSTOMER FOR EVALUATION. ALSO RECEIVED A PHOTO OF ACTUAL DEVICE AND REPORTED MALFUNCTION BUT DID NOT RECEIVE SAMPLE OF ACTUAL DEVICE. 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. A DHR REVIEW IS NOT REQUIRED. REFER TO CAPA (B)(4) FOR COMPLETE DOCUMENTATION AND ACTION PLANS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USING THE 23 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THE PUSH BUTTON DID NOT FULLY RETRACT THE NEEDLE LEAVING THE NEEDLE PARTIALLY EXPOSED. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778884 23 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD COLLECTION SET JKA BECTON, DICKINSON & CO., (BD) 6131789 00382903673421

    Patients

    Seq Age Sex Outcome Treatment
    1 Other