BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER MULTIPLE SAMPLE LUER ADAPTER

    MDR report key: 11276692 · Received February 3, 2021

    Report

    Report Number
    1024879-2021-00081
    Event Type
    Malfunction
    Date Received
    February 3, 2021
    Date of Event
    January 14, 2021
    Report Date
    January 20, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903672900
    PMA / PMN Number
    K991088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. (B)(4). INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER NON PATIENT NEEDLE SEPARATES FROM THE HOLDER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO. 367290, BATCH NO. 0120196. IT WAS REPORTED THAT THE PLASTIC END OF THE BD NEEDLE SPLIT OFF INSIDE A PATIENTS ARTERIAL PORT. PER EMAIL: A USER FACILITY NURSE REPORTED VIA FAX THAT THE PLASTIC END OF THE BD NEEDLE SPLIT OFF INSIDE OF A PATIENT'S ARTERIAL PORT WHEN TRYING TO REMOVE THE VACUTAINER FROM THE PORT AFTER DRAWING LABS. THE BROKEN END WAS REMOVED WITH ALCOHOL PADS, TOURNIQUET, AND PLIERS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168543 BD VACUTAINER MULTIPLE SAMPLE LUER ADAPTER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367290 0120196 50382903672900

    Patients

    Seq Age Sex Outcome Treatment
    1