BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE K2EDTA PLH 13X75 3.0 PLBLCE GLD

    MDR report key: 9900678 · Received March 30, 2020

    Report

    Report Number
    9617032-2020-00299
    Event Type
    Malfunction
    Date Received
    March 30, 2020
    Date of Event
    February 24, 2020
    Report Date
    April 21, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS OBSERVED. HOWEVER, 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TUBE K2EDTA PLH 13X75 3.0 PLBLCE GLD FILLED PARTIALLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBES ONLY PARTIALLY FILLED".

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TUBE K2EDTA PLH 13X75 3.0 PLBLCE GLD FILLED PARTIALLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBES ONLY PARTIALLY FILLED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365301 TUBE K2EDTA PLH 13X75 3.0 PLBLCE GLD BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 07201006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other