BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES

    MDR report key: 7533813 · Received May 22, 2018

    Report

    Report Number
    2243072-2018-01048
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    July 24, 2013
    Report Date
    June 6, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    K971449
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BRAND NAME UPDATED TO BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES. COMMON DEVICE NAME UPDATED TO BLOOD SPECIMEN COLLECTION DEVICE. MEDICAL DEVICE TYPE UPDATED TO JKA. MEDICAL DEVICE MANUFACTURER UPDATED TO BROKEN BOW AFTER BEING INCORRECTLY FILED UNDER (B)(4). UDI# UPDATED TO (B)(4). DEVICE EXPIRATION DATE UPDATED TO 10/31/2013. 510(K)# UPDATED TO K971449. DEVICE MANUFACTURE DATE UPDATED TO 05/03/2012. MRF# MDR WAS FILED UNDER (B)(4) (2243072) MFR # BUT SHOULD HAVE BEEN FILED UNDER A BROKEN BOW MFR# (1917413).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 THAT EDTA TUBES WERE UNDERFILLING. NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376956 BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 2124355

    Patients

    Seq Age Sex Outcome Treatment
    1 Other