BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23G X 0.75IN NEEDLE X 7IN TUBING BD SAFETY-LOK¿ BC SET WITH LUER ADAPTER

    MDR report key: 7099877 · Received December 8, 2017

    Report

    Report Number
    1024879-2017-00923
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Date of Event
    December 20, 2016
    Report Date
    November 22, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    K980414
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. BD RECEIVED SEVEN (7) PHOTOS THAT SHOWED THE BD SAFETY-LOK BLOOD COLLECTION HOLDER BEING USED WITH NON BD PRODUCT AS NOTED IN THE EVENT DESCRIPTION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6153642. 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. BASED ON THE INVESTIGATION RESULTS, NO ROOT CAUSE FROM THE MANUFACTURING PROCESS WAS IDENTIFIED AS A CONTRIBUTOR TO THE REPORTED FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE, SAFETY-LOK BLOOD COLLECTION SET, 7-INCH TUBING, LUER ADAPTER, 23 GAUGE NEEDLE, HAS BEEN COMING APART FROM THE SAFETY HOLDER. NO MEDICAL INTERVENTION OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878394 23G X 0.75IN NEEDLE X 7IN TUBING BD SAFETY-LOK¿ BC SET WITH LUER ADAPTER BLOOD COLLECTION SET JKA BECTON, DICKINSON & CO., (BD) 6153642

    Patients

    Seq Age Sex Outcome Treatment
    1 Other