BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLUS CITRATE TUBE 2.7ML WITH LIGHT BLUE HEMOGARD CLOSURE

    MDR report key: 7084525 · Received December 5, 2017

    Report

    Report Number
    9617032-2017-00461
    Event Type
    Malfunction
    Date Received
    December 5, 2017
    Date of Event
    March 31, 2017
    Report Date
    January 22, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    00382903630950
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITHOUT A 510K NUMBER BUT THIS DEVICE DOES HAVE A 510K ASSOCIATED WITH IT. THE 510K NUMBER IS K013971.

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6319950. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE, BD VACUTAINER® PLUS CITRATE TUBE 2.7ML WITH LIGHT BLUE HEMOGARD CLOSURE, HAD BLOOD LEAKING AFTER THE STOPPER POPPED OFF. NO MEDICAL INTERVENTION OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863485 BD VACUTAINER® PLUS CITRATE TUBE 2.7ML WITH LIGHT BLUE HEMOGARD CLOSURE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON AND COMPANY (BD) 6319950 00382903630950

    Patients

    Seq Age Sex Outcome Treatment
    1 Other