BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SAFETY-LOK¿ BCS WITH PRE-ATTACHED HOLDER, 21G 7IN TUBE

    MDR report key: 7008369 · Received November 7, 2017

    Report

    Report Number
    1024879-2017-00336
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Date of Event
    November 6, 2015
    Report Date
    January 26, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    K980414
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    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 RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5161654. 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.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITH AN INCORRECT DATE OF EVENT. THE CORRECT DATE OF EVENT IS (B)(6) 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE UNPACKING THE BD VACUTAINER® SAFETY-LOK¿ BCS WITH PRE-ATTACHED HOLDER, 21G 7IN TUBE THE SAFETIES FELL OFF. THIS RESULTED IN THE USER BEING STUCK PRIOR TO USE. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785647 BD VACUTAINER® SAFETY-LOK¿ BCS WITH PRE-ATTACHED HOLDER, 21G 7IN TUBE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO., (BD) 5161654

    Patients

    Seq Age Sex Outcome Treatment
    1 Other