BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    13X100 MM 6.0 ML BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE

    MDR report key: 6745858 · Received July 26, 2017

    Report

    Report Number
    1917413-2017-00077
    Event Type
    Malfunction
    Date Received
    July 26, 2017
    Date of Event
    July 18, 2014
    Report Date
    August 16, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    K981013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED SIX DIFFERENT LOT NUMBERS ASSOCIATED WITH THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2003772, MEDICAL DEVICE EXPIRATION DATE: 6/30/2013, DEVICE MANUFACTURE DATE: 1/3/2012. MEDICAL DEVICE LOT #: 2065989, MEDICAL DEVICE EXPIRATION DATE: 8/31/2013, DEVICE MANUFACTURE DATE: 3/5/2012. MEDICAL DEVICE LOT #: 2254271, MEDICAL DEVICE EXPIRATION DATE: 2/28/2014, DEVICE MANUFACTURE DATE: 9/10/2012. MEDICAL DEVICE LOT #: 2306240, MEDICAL DEVICE EXPIRATION DATE: 4/30/204, DEVICE MANUFACTURE DATE: 11/1/2012. MEDICAL DEVICE LOT #: 3007272, MEDICAL DEVICE EXPIRATION DATE: 6/30/2014, DEVICE MANUFACTURE DATE: 1/7/2013. MEDICAL DEVICE LOT #: 3122096, MEDICAL DEVICE EXPIRATION DATE: 10/31/2014, DEVICE MANUFACTURE DATE: 5/2/2013. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS 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. UDI #: (B)(4).

    Additional Manufacturer Narrative · 1

    IN ADDITION TO THE NO SAMPLE INVESTIGATION PROVIDED ON THE INITIAL MDR, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON 7/27/2017. THE DETAILS FOR THE REVIEW ARE AS FOLLOWS: RESULTS: ALL OF THE MANUFACTURING RECORDS WERE REVIEWED FOR THE LOT NUMBERS LISTED ABOVE WITH NO ISSUES BEING FOUND. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. CONCLUSION: AS PREVIOUSLY REPORTED, 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 SINCE (B)(6) OF 2012, 13X100 MM 6.0 ML BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBES HAVE CRACKED WHEN THEY WERE FROZEN AT -80 DEGREES. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523530 13X100 MM 6.0 ML BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other