BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® C&S TRANSFER STRAW KIT

    MDR report key: 7558462 · Received May 31, 2018

    Report

    Report Number
    1917413-2018-02110
    Event Type
    Malfunction
    Date Received
    May 31, 2018
    Date of Event
    May 24, 2017
    Report Date
    May 4, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JSM
    UDI-DI
    50382903649537
    PMA / PMN Number
    K024240
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT #: 6119578. MEDICAL DEVICE EXPIRATION DATE: 11/30/2017. DEVICE MANUFACTURE DATE: 04/28/2016. MEDICAL DEVICE LOT #: 6210614. MEDICAL DEVICE EXPIRATION DATE: 02/28/2018. DEVICE MANUFACTURE DATE:07/28/2016. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. BD HAS INITIATED A CAPA TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE(S) OF THIS PRODUCT ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® C&S TRANSFER STRAW KIT HAD A ADDITIVE LABELLING DISCREPANCY. NO REPORT OF MEDICAL INTERVENTION OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398105 BD VACUTAINER® C&S TRANSFER STRAW KIT TRANSPORT CULTURE MEDIUM JSM BECTON, DICKINSON & CO. 6085670 50382903649537

    Patients

    Seq Age Sex Outcome Treatment
    1 Other