BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER K2E 7.2MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 11136187 · Received January 7, 2021

    Report

    Report Number
    9617032-2021-00025
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Date of Event
    December 18, 2020
    Report Date
    February 10, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. 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. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNDERFILLING OCCURRED WHILE USING BD VACUTAINER® K2E 7.2MG PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " SOME STAFF HERE HAVE EXPRESSED THAT SOME EDTAS WITH BATCH NUMBER 8082252 DO NOT HAVE VACUUM AS THEY DONT FILL UP TO THE MARK."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNDERFILLING OCCURRED WHILE USING BD VACUTAINER® K2E 7.2MG PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " SOME STAFF HERE HAVE EXPRESSED THAT SOME EDTAS WITH BATCH NUMBER (B)(4) DO NOT HAVE VACUUM AS THEY DONT FILL UP TO THE MARK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26058 BD VACUTAINER K2E 7.2MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1