BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 7472759 · Received April 30, 2018

    Report

    Report Number
    1917413-2018-01040
    Event Type
    Malfunction
    Date Received
    April 30, 2018
    Date of Event
    November 17, 2016
    Report Date
    October 2, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE EVENT OR PROBLEM DESCRIPTION IS CORRECTED TO IT WAS REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD FM IN THE GEL. NO SERIOUS INJURY OR MEDICAL INTERVENTION. MEDICAL DEVICE BRAND NAME IS CORRECTED TO BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. MEDICAL DEVICE MANUFACTURER IS CORRECTED TO BECTON, DICKINSON & CO. COMMON DEVICE NAME IS CORRECTED TO BLOOD SPECIMEN COLLECTION DEVICE. UNIQUE IDENTIFIER (UDI) # IS CORRECTED TO (B)(4). DEVICE AVAILABLE FOR EVALUATION IS CORRECTED TO NO. MANUFACTURING LOCATION IS CORRECTED TO BECTON, DICKINSON & CO. DEVICE RETURNED TO MANUFACTURER IS CORRECTED TO NO. DEVICE EVALUATED BY MANUFACTURER IS CORRECTED TO NO. RESULTS CODES ARE CORRECTED TO 114.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE MANUFACTURER CHANGED TO BECTON, DICKINSON & CO. MANUFACTURING LOCATION CHANGED TO (B)(4).

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS FILED UNDER THE WRONG MFR#1917413-2018-01040 FOR (B)(4) IT SHOULD HAVE BEEN REPORTED AS 1024879-2018-00575 FOR (B)(4). THE CORRECT MANUFACTURING SITE IS SUMTER AND HAS BEEN CORRECTED IN THE FOLLOWING FIELDS. MEDICAL DEVICE MANUFACTURER CHANGED TO (B)(4). MANUFACTURING LOCATION CHANGED TO (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD FM IN THE GEL. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR FM WITH THE INCIDENT LOT WAS OBSERVED. 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 THE BD VACUTAINER® C&S BORIC ACID KIT SODIUM BORATE/ FORMATE HAD FOREIGN MATTER IN GEL OF SST TUBE. NO SERIOUS INJURY MEDICAL. INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317050 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 6246745

    Patients

    Seq Age Sex Outcome Treatment
    1 Other