BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER® EDTA LAVENDER TUBES

    MDR report key: 7470347 · Received April 27, 2018

    Report

    Report Number
    2618282-2018-00362
    Event Type
    Malfunction
    Date Received
    April 27, 2018
    Date of Event
    April 30, 2015
    Report Date
    June 1, 2018
    Manufacturer
    BD CARIBE LTD.
    Product Code
    JKA
    PMA / PMN Number
    K991702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE IS UNKNOWN. LOT NUMBER IS UNKNOWN. MANUFACTURE DATE IS UNKNOWN. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    510(K)# UPDATED TO K991702.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE BD MICROTAINER® EDTA LAVENDER TUBES, THE CUSTOMER USER NOTICED THAT IT WAS THE INCORRECT PRODUCT AFTER HAVING BEEN TOLD IT WAS THE REPLACEMENT FOR A DISCONTINUED TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313372 BD MICROTAINER® EDTA LAVENDER TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BD CARIBE LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other