BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET PRE-ATTACHED HOLDER 23G NEEDLE

    MDR report key: 7078016 · Received December 3, 2017

    Report

    Report Number
    1024879-2017-00774
    Event Type
    Malfunction
    Date Received
    December 3, 2017
    Date of Event
    December 7, 2015
    Report Date
    January 24, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITHOUT A 510K NUMBER. THE 510K OF THIS DEVICE IS K030573.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN MEDICAL DEVICE LOT: UNKNOWN. INITIAL REPORTER PHONE #: (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN. RESULTS: FOUR PHOTOGRAPHS WERE RETURNED TO CONFIRM THE CUSTOMER'S COMPLAINT. A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. 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 A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET PRE-ATTACHED HOLDER 23G NEEDLE HAD BLOOD LEAKAGE AT VENIPUNCTURE AND AT THE SLEEVE DURING BLOOD COLLECTION. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857276 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET PRE-ATTACHED HOLDER 23G NEEDLE BLOOD COLLECTION NEEDLE JKA BECTON, DICKINSON & CO., (BD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other