BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER®

    MDR report key: 7573538 · Received June 6, 2018

    Report

    Report Number
    2243072-2018-01248
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    February 12, 2018
    Report Date
    May 11, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4). INVESTIGATION SUMMARY: AS BD LIFE SCIENCES - PREANALYTICAL SYSTEMS HAD NOT RECEIVED ANY SAMPLE, PHOTO, CATALOG NUMBER, AND/OR LOT NUMBER FROM THE CUSTOMER FACILITY FOR EVALUATION, AN INVESTIGATION COULD NOT BE PERFORMED AS NO INFORMATION WAS AVAILABLE FOR REVIEW. INVESTIGATION CONCLUSION: AS BD LIFE SCIENCES - PREANALYTICAL SYSTEMS HAD NOT RECEIVED ANY SAMPLE, PHOTO, CATALOG NUMBER, AND/OR LOT NUMBER FROM THE CUSTOMER FACILITY FOR EVALUATION, AN INVESTIGATION COULD NOT BE PERFORMED AS NO INFORMATION WAS AVAILABLE FOR REVIEW. ROOT CAUSE DESCRIPTION: AS BD LIFE SCIENCES - PREANALYTICAL SYSTEMS HAD NOT RECEIVED ANY SAMPLE, PHOTO, CATALOG NUMBER, AND/OR LOT NUMBER FROM THE CUSTOMER FACILITY FOR EVALUATION, AN INVESTIGATION COULD NOT BE PERFORMED AS NO INFORMATION WAS AVAILABLE FOR REVIEW. RATIONALE: AS BD LIFE SCIENCES - PREANALYTICAL SYSTEMS HAD NOT RECEIVED ANY SAMPLE, PHOTO, CATALOG NUMBER, AND/OR LOT NUMBER FROM THE CUSTOMER FACILITY FOR EVALUATION, AN INVESTIGATION COULD NOT BE PERFORMED AS NO INFORMATION WAS AVAILABLE FOR REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD VACUTAINER® PRODUCT UNDER FILLED. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418816 BD VACUTAINER® BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other