BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD IAG BC PRO GLOBAL

    MDR report key: 20482135 · Received October 18, 2024

    Report

    Report Number
    1710034-2024-01167
    Event Type
    Malfunction
    Date Received
    October 18, 2024
    Date of Event
    September 20, 2024
    Report Date
    October 28, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903810239
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THIS TYPE OF PRODUCT MALFUNCTION DURING THE PRODUCTION PROCESS. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. COMPLAINT WITH MULTIPLE FAILURES, SOME REPORTABLE SOME NOT REPORTABLE. THE CUSTOMER IS NOT ABLE TO INDICATE WHICH LOTS WERE USED/ OR PRODUCED A GIVEN FAILURE. BELOW ARE THE POTENTIAL LOT NUMBERS. "THE LOT# WITH THE STAR HAS BEEN ONE OF THE PREDOMINANT ONES ". 4110703. 4177313*. 4059387. 3114865. 3319027. 3360115.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD IAG BC PRO GLOBAL BLOOD CONTROL FEATURE DOES NOT WORK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MULTIPLE ISSUE WITH IV INSERTION, COLLAPSING VEIN, BLOWING VEIN, CANNULA FEELS STICKY AND LARGER AT TIP. VALVE IS FAILING ON SOME. HAVE SEVERAL SET ASIDE MANY DIFFERENT LOT NUMBERS. NOT ALL ARE AFFECTED IN THE SAME LOT NUMBERS. CUSTOMER DID NOT COMMUNICATE INCIDENT DATE, QUANTITY AFFECTED, LOT NUMBERS AFFECTED. CAT# OF PRODUCT BEING COMPLAINED: BD381023 ACK SENT WITH FOLLOW UP QUESTIONS: 1. PLEASE SHARE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE 2. IN THE INITIAL EMAIL IT MENTIONED "MULTIPLE ISSUE WITH IV INSERTION". COULD YOU PLEASE CONFIRM ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED IN ANY OF THE EVENTS? IF YES PLEASE CONFIRM THE DETAILS. THE LOT# WITH THE STAR HAS BEEN ONE OF THE PREDOMINANT ONES. IT'S BEEN AN ISSUE THAT HAS BEEN HARD TO ARTICULATE AS THE STAFF HAVE PLACED THE BLAME ON THEMSELVES. FURTHER DISCUSSION HAS LED TO THE IDENTIFICATION OF THE IV FEELING STICKY, UNABLE TO ADVANCE INTO THE VEIN, AND THE SKIN ROLLING INTO THE INSERTION SITE. RESULTING IN MULTIPLE POKES, BLOWING THE VEIN, BRUISING, HEMATOMAS, AND PAINFUL INSERTION. CUSTOMER RESPONSE RECEIVED ON 08-OCT-2024. WHEN THE NURSE INSERTS INTO THE VEIN THE VALVE DOESN'T STOP THE BLOOD FROM FLOWING. I AM UNSURE WHAT LOT # AND ONLY HEARD FROM ONE NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959919 BD IAG BC PRO GLOBAL PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903810239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown