BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 7573388 · Received June 6, 2018

    Report

    Report Number
    9617032-2018-01336
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    April 11, 2017
    Report Date
    May 10, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679558
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL LOT NUMBERS IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6299929, MEDICAL DEVICE EXPIRATION DATE: 04/30/2018, DEVICE MANUFACTURE DATE: 10/25/2016. MEDICAL DEVICE LOT #: 6152903, MEDICAL DEVICE EXPIRATION DATE: 11/30/2017, DEVICE MANUFACTURE DATE: 05/31/2016. " BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. THIS COMPLAINT IS CONFIRMED TO BE WITHIN THE SCOPE OF A KNOWN ISSUE. QUALITY HAS PREVIOUSLY REVIEWED, EVALUATED AND INVESTIGATED THIS FAILURE MODE. NO FURTHER ACTION IS REQUIRED AT THIS TIME. BASED ON EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT MEETS THE CRITERIA FOR A PREVIOUSLY INVESTIGATED COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES DID NOT FULLY FILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417615 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 6333607 50382903679558

    Patients

    Seq Age Sex Outcome Treatment
    1 Other