BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD VACUTAINER BLOOD COLLECTION TUBE

    MDR report key: 12639989 · Received October 15, 2021

    Report

    Report Number
    2243072-2021-02515
    Event Type
    Malfunction
    Date Received
    October 15, 2021
    Date of Event
    September 20, 2021
    Report Date
    September 24, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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. 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. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC MATERIAL/ LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE UNSPECIFIED BD VACUTAINER BLOOD COLLECTION TUBE, THE DEVICE EXPERIENCED UNSPECIFIED BD VACUTAINER BLOOD COLLECTION TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: LAST FRIDAY, AN EMPLOYEE CAME TO ME WITH A COMPLAINT ABOUT VACUUM TUBES WHEN USING BD VACUTAINERS PUSH BUTTON. PROBLEM IS THAT THE VACUUM TUBE DOES NOT STAY IN PLACE AND HAS TO BE HELD DURING THE BLOOD COLLECTION. WITH THE FIRST ONE OUT OF THE PACKAGE, HE COULD RECREATE IT. ON THE DEPARTMENT ALSO SEVERAL OTHER TUBES. I RECOGNIZE THIS PROBLEM FROM THE PAST WHEN A DIFFERENT TYPE OF RUBBER WAS USED FOR THE RUBBER IN THE SLEEVE. I BELIEVE THAT ONE CAME FROM (B)(6) AND THE OTHER FROM AMERICA. WERE SAMPLES KEPT FOR RESEARCH? IF SO, HOW MANY AND WHERE CAN WE COLLECT THEM? BOX FULL OF -1, THIS TESTED (NOT DIRTY) SAMPLE IS ENCLOSED TOGETHER WITH THE TESTED SAMPLING TUBE. THE CUSTOMERS DID NOT USE A DISCARD TUBE AND ALSO NO GLASS CITRATE TUBE OR GLASS CTAD TUBE WERE DRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541138 UNSPECIFIED BD VACUTAINER BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1