BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7060215 · Received November 27, 2017

    Report

    Report Number
    1024879-2017-00284
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    May 26, 2016
    Report Date
    October 23, 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
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS - A SAMPLE WAS NOT RETURNED FOR EVALUATION. A PHOTO WAS SENT THAT SHOWED THE NEEDLE IN THE FULLY EXTENDED POSITION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT #6012842. 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. CAPA (B)(4) HAS BEEN INITIATED TO DOCUMENT THE INVESTIGATION PATH, ROOT CAUSE ANALYSIS AND REMEDIATION PLAN TO INCLUDE CORRECTIVE AND PREVENTIVE ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT IN THE 23 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH 12 IN. TUBING AND LUER ADAPTER SET. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840816 23 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD COLLECTION SET JKA BECTON, DICKINSON & CO., (BD) 6012842 50382903673426

    Patients

    Seq Age Sex Outcome Treatment
    1 Other