BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7012008 · Received November 8, 2017

    Report

    Report Number
    1024879-2017-00200
    Event Type
    Malfunction
    Date Received
    November 8, 2017
    Date of Event
    January 7, 2016
    Report Date
    October 20, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    00382903673360
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHLEBOTOMIST

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.(B)(6). RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5058588, 5140680, 5085646, 5169840, 5063525 AND 5027924. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHLEBOTOMY TEAM WAS EXPERIENCING TUBE POP OFF AT THE BACK OF THE LUER ADAPTOR ON 23 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET. NO MUCOUS MEMBRANE EXPOSURE. NO SAMPLES WERE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791596 23 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD COLLECTION SET. JKA BECTON, DICKINSON & CO., (BD) 5058588 00382903673360

    Patients

    Seq Age Sex Outcome Treatment
    1 Other