BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE K2EDTA PLH 13X75 3.0 PLBLCE GLD

    MDR report key: 9273678 · Received November 4, 2019

    Report

    Report Number
    9617032-2019-01253
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Date of Event
    September 26, 2019
    Report Date
    November 14, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 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 NOT OBSERVED. 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 · 0

    IT WAS REPORTED THAT UNDERFILL OCCURRED DURING USE WITH A TUBE K2EDTA PLH 13X75 3.0 PLBLCE GLD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CAP YELLOW STEEL TUBE DOES NOT FILL SUFFICIENTLY. DURING DONATION."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNDERFILL OCCURRED DURING USE WITH A TUBE K2EDTA PLH 13X75 3.0 PLBLCE GLD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CAP YELLOW STEEL TUBE DOES NOT FILL SUFFICIENTLY. DURING DONATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065390 TUBE K2EDTA PLH 13X75 3.0 PLBLCE GLD BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other