BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2EDTA TUBE

    MDR report key: 7100198 · Received December 8, 2017

    Report

    Report Number
    9617032-2017-00303
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Date of Event
    August 29, 2016
    Report Date
    November 23, 2017
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K981013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: NO SAMPLES WERE RETURNED, BUT PHOTOS WERE ATTACHED SHOWING A SHELF-PACK OF TUBES WITH NO BANDING INFORMATION ON THEM. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT #6153609. CONCLUSION: EVALUATION OF THE RETURNED PHOTOGRAPH CONFIRMED THE REPORTED DEFECT. THE ROOT CAUSE FOR THE DEFECT IS THAT THE INK RESERVOIR RAN LOW DURING THE PROCESS AND PRINTING OF THE TUBES FAILED. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® K2EDTA TUBE HAD AN ABSENCE OF SILKSCREEN ON THE TUBES OF 1 TRAY. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880845 BD VACUTAINER® K2EDTA TUBE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON AND COMPANY (BD) 6153609

    Patients

    Seq Age Sex Outcome Treatment
    1 Other