BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE

    MDR report key: 6641984 · Received June 14, 2017

    Report

    Report Number
    1917413-2017-00018
    Event Type
    Malfunction
    Date Received
    June 14, 2017
    Date of Event
    January 3, 2017
    Report Date
    June 13, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    K981013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TWO SEPARATE LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6102725, MEDICAL DEVICE EXPIRATION DATE: 08/31/2017, DEVICE MANUFACTURE DATE: 04/11/2016. MEDICAL DEVICE LOT #: 6090979, MEDICAL DEVICE EXPIRATION DATE: 08/31/2017, DEVICE MANUFACTURE DATE: 03/30/2016. (B)(6). RESULTS: TEN SAMPLES, FIVE FROM EACH LOT NUMBER, WERE RETURNED FOR EVALUATION. ALL CUSTOMER SAMPLES WERE DRAW TESTED AND MEASURED FOR OVERALL TUBE HEIGHT. TWENTY RETENTION SAMPLES WERE PULLED, 10 SAMPLES FROM EACH LOT, AND WERE DRAW TESTED AND MEASURED FOR OVERALL TUBE HEIGHT. ALL TUBES, BOTH CUSTOMER SAMPLES AND RETENTION SAMPLES, WERE WITHIN SPECIFICATION LIMITS. THERE WAS NO STOPPER PULL OUT, CREEPOUT, OR POPOFF OBSERVED DURING THE DRAW TESTING. ALL TUBE HEIGHT WAS WITHIN SPECIFICATION OF NO GREATER THAN 3.248. A DEVICE HISTORY RECORD WAS NOT REVIEWED BUT THERE WERE NO RELATED QUALITY NOTIFICATIONS AND ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. CONCLUSION: 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STOPPER OF A BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE STAYED CONNECTED TO THE NEEDLE, PULLED OUT OF THE TUBE, AND BLOOD LEAKED WHEN THE TUBE WAS WITHDRAWN FROM A HOLDER DURING A BLOOD COLLECTION. IT WAS ALSO REPORTED THAT THIS HAS HAPPENED WITH DIFFERENT UNITS (TWO LOT NUMBERS WERE PROVIDED) WITH DIFFERENT EMPLOYEES ON NUMEROUS OCCASIONS. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420517 BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other