BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER

    MDR report key: 12870992 · Received November 24, 2021

    Report

    Report Number
    1024879-2021-00825
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    September 27, 2021
    Report Date
    January 14, 2022
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    K991088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE FOLLOWING FIELDS WERE CORRECTED: B2: ADVERSE TYPE: PRODUCT PROBLEM B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER HAD INSUFFICIENT BLOOD FLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLACEMENT OF MY ADAPTER WITH VACUTAINER FOR BLOOD SAMPLING. NO VENOUS RETURN, UNABLE TO DRAW BLOOD" H2: TYPE OF REPORTABLE EVENTS: MALFUNCTION H5: IMDRF ANNEX A GRID: A140303 INVESTIGATION SUMMARY THE LUER ADAPTER IV AND NP SHIELDS FOR LOT NUMBER 1081842 COULD NOT BE EVALUATED FOR THE INDICATED FAILURE MODE BECAUSE THE LUER ADAPTER ASSEMBLY WAS NOT PROVIDED. THEREFORE, TEN (10) RETENTION SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING AND NO DEFECTS RELATED TO INSUFFICIENT FLOW WERE OBSERVED.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER HAD INSUFFICIENT BLOOD FLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLACEMENT OF MY ADAPTER WITH VACUTAINER FOR BLOOD SAMPLING. NO VENOUS RETURN, UNABLE TO DRAW BLOOD".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER A PATIENT GOT INFECTED AND REQUIRED MEDICAL INTERVENTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "- AN INFECTION"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1765932 BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 1081842

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention