BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN

    MDR report key: 7447678 · Received April 20, 2018

    Report

    Report Number
    2243072-2018-00518
    Event Type
    Malfunction
    Date Received
    April 20, 2018
    Date of Event
    November 9, 2016
    Report Date
    June 8, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    UDI-DI
    50382903687744
    PMA / PMN Number
    K101502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE TYPE UPDATED TO: JKA. 510(K)# UPDATED TO: K101502.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE EXPIRATION DATE: 2017-05-31, DEVICE MANUFACTURE DATE: 2016-08-31, MEDICAL DEVICE LOT #: 160204, MEDICAL DEVICE EXPIRATION DATE: 2017-04-30, DEVICE MANUFACTURE DATE: 2016-04-08. (B)(6). FOR OEM MANUFACTURING SITES: IN THIS MDR, (B)(4) HAS BEEN LISTED AS (B)(4)MANUFACTURING SITE. (B)(6). BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN GAVE DISCREPANT RESULTS AS PER AN INVESTIGATION BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291248 BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON SEE H10 50382903687744

    Patients

    Seq Age Sex Outcome Treatment
    1 Other