BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ TUBES

    MDR report key: 7498929 · Received May 9, 2018

    Report

    Report Number
    2243072-2018-01064
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    April 4, 2017
    Report Date
    May 8, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE BRAND NAME: UNKNOWN, USED GENETIC NAME. COMMON DEVICE NAME: UNKNOWN, USED GENETIC NAME. MEDICAL DEVICE TYPE : UNKNOWN. UNIQUE IDENTIFIER (UDI) # : UNKNOWN. MEDICAL DEVICE CATALOG #: UNKNOWN. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. DEVICE MANUFACTURE DATE: UNKNOWN. RESULT: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BD VACUTAINER® PST¿ TUBES WERE HAVING GEL SMEAR , NO REPORT OF MEDICAL INTERVENTIONS OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343125 BD VACUTAINER® PST¿ TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other