BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CITRATE TUBES 4.5 13X75 NA CITRATE (0.105M = 3.2%)

    MDR report key: 7017668 · Received November 10, 2017

    Report

    Report Number
    9617032-2017-00169
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Date of Event
    November 9, 2015
    Report Date
    January 24, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITHOUT A 510K NUMBER. THE 510K OF THE DEVICE IS K013971.

    Additional Manufacturer Narrative · 1

    RESULTS: NO SAMPLES OR PHOTOS WERE RETURNED FOR EVALUATION. TWENTY RETAINED SAMPLES FROM THE IMPLICATED LOT NUMBER WERE DRAWN WITH DEIONIZED WATER. THEY WERE THEN CENTRIFUGED AT 1500G FOR 15 MIN. NONE SHOWED ANY SIGNS OF DAMAGE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5132225. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS¿ INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® CITRATE TUBES 4.5 13X75 NA CITRATE (0.105M = 3.2%) TUBE BROKE DURING USE ON TWO OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTIONS. REP SUSPECTED FRAGILISED TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802248 BD VACUTAINER® CITRATE TUBES 4.5 13X75 NA CITRATE (0.105M = 3.2%) BLOOD COLLECTION TUBE JKA BECTON, DICKINSON AND COMPANY (BD) 5132225

    Patients

    Seq Age Sex Outcome Treatment
    1 Other