BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD VACUTAINER¿ SST¿ BLOOD COLLECTION TUBES

    MDR report key: 9446932 · Received December 10, 2019

    Report

    Report Number
    2243072-2019-02781
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    October 24, 2019
    Report Date
    December 19, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE CUSTOMER DID NOT PROVIDE BD PAS WITH PRODUCT CATALOG NUMBER OR LOT NUMBER INFORMATION, WHEN REQUESTED. AFTER SEVERAL FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, BD PAS HAS CLOSED THIS CUSTOMER COMPLAINT. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LH AND PROLACTIN RESULTS WERE HIGH WITH AN UNSPECIFIED BD VACUTAINER¿ SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (3 OF 3 COMPLAINTS). IT WAS REPORTED THAT THE LH AND PROLACTIN RESULTS WERE HIGH.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LH AND PROLACTIN RESULTS WERE HIGH WITH AN UNSPECIFIED BD VACUTAINER¿ SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (3 OF 3 COMPLAINTS) IT WAS REPORTED THAT THE LH AND PROLACTIN RESULTS WERE HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243455 UNSPECIFIED BD VACUTAINER¿ SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other