BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SINGLE USE HOLDER

    MDR report key: 7087706 · Received December 6, 2017

    Report

    Report Number
    1917413-2017-00551
    Event Type
    Malfunction
    Date Received
    December 6, 2017
    Date of Event
    April 21, 2017
    Report Date
    January 24, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903648158
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITH THE 510K NUMBER LISTED AS K933386. IT IS CORRECTED TO READ PRE-AMENDMENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT # UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(4) DEVICE MANUFACTURE DATE: UNKNOWN. RESULTS: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TUBES HELD WITH BD VACUTAINER® SINGLE USE HOLDER TOO TIGHTLY CAUSE THE CAP TO SEPARATE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865497 BD VACUTAINER® SINGLE USE HOLDER BLOOD COLLECTION DEVICE JKA BECTON, DICKINSON & CO. UNKNOWN 50382903648158

    Patients

    Seq Age Sex Outcome Treatment
    1 Other