BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER® BLOOD COLLECTION TUBES

    MDR report key: 7077977 · Received December 3, 2017

    Report

    Report Number
    2618282-2017-00031
    Event Type
    Malfunction
    Date Received
    December 3, 2017
    Date of Event
    June 22, 2017
    Report Date
    January 24, 2018
    Manufacturer
    BD CARIBE LTD.
    Product Code
    JKA
    PMA / PMN Number
    K991702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITHOUT A 510K NUMBER BUT THIS DEVICE 510K IS K991702.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: (B)(6). RESULTS - CONFIRMED: BD LIFE SCIENCES - PREANALYTICAL SYSTEMS WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH ONE ACTUAL SAMPLE PROVIDED BY THE CUSTOMER. THE DEFECT WAS NOT OBSERVED IN THE RETENTION SAMPLES. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED FOR THE INCIDENT LOT AND NO MANUFACTURING ISSUES WERE REPORTED. CONCLUSION - THE MOST PROBABLE ROOT CAUSE ASSOCIATED TO THE REPORTED ISSUE MAY BE DUE TO MOLDING PROCESS ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CENTRIFUGATION, BD MICROTAINER® BLOOD COLLECTION TUBES LEAKED. USER REPORTED SEEING CRACKS AND SPLITS IN THE TUBING. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857273 BD MICROTAINER® BLOOD COLLECTION TUBES BLOOD COLLECTION TUBE JKA BD CARIBE LTD. 7095632

    Patients

    Seq Age Sex Outcome Treatment
    1 Other