BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE K2EDTA PLH 13X75 3.0 PLBL LAV

    MDR report key: 10402624 · Received August 13, 2020

    Report

    Report Number
    1917413-2020-00689
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Date of Event
    July 22, 2020
    Report Date
    August 28, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678568
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED 100 CUSTOMER SAMPLES FROM THE CUSTOMER FOR EVALUATION. ONE PHOTO WAS RECEIVED. THE CUSTOMER¿S FAILURE MODE OF ¿INCORRECT CAP COLOR¿ WAS SEEN IN THE CUSTOMER SAMPLES AND PHOTO AS THE SHIELD IS THE INCORRECT COLOR.BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TUBE K2EDTA PLH 13X75 3.0 PLBL LAV HAD AN INCORRECTLY COLORED CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BLUE CAP IN EDTA TUBES CUSTOMER FOUND ONE BLUE CAP IN EDTA TUBES.".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TUBE K2EDTA PLH 13X75 3.0 PLBL LAV HAD AN INCORRECTLY COLORED CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BLUE CAP IN EDTA TUBES CUSTOMER FOUND ONE BLUE CAP IN EDTA TUBES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869639 TUBE K2EDTA PLH 13X75 3.0 PLBL LAV BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367856 9280906 50382903678568

    Patients

    Seq Age Sex Outcome Treatment
    1 Other