BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ TUBERCULIN SYRINGE

    MDR report key: 16502844 · Received March 8, 2023

    Report

    Report Number
    8041187-2023-00083
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    February 9, 2023
    Report Date
    March 31, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS THE LOT NUMBER IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD¿ TUBERCULIN SYRINGE THE PLUNGER WAS LOOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD COMPANY , MY PARTNER AND I ARE INTRAVENOUS DRUG USERS AND HAVE BEEN FOR A LONG TIME , AND NEVER IN OUR WHOLE TIME AS USERS HAVE WE EVER HAD AN ISSUE WITH YOUR 1ML SYRINGES UNTIL RECENTLY. WE HAD A BATCH OF YOUR SYRINGES THAT WERE FAULTY IN A MAJOR WAY, THEY CAUSED SO MUCH DAMAGE TO OUR ARMS AND VEINS DUE TO THE PLUNGER BEING TO LOSE, IT WOULDN¿T JACK BACK SO WE CONSTANTLY THOUGHT THE NEEDLE WASN¿T IN. WE DIDN¿T REALISE IT WAS THE NEEDLES UNTIL WE WENT AND GOT DIFFERENT ONES FROM SOMEWHERE ELSE. YOU HAVE NO IDEA THE DAMAGE WE HAVE INFLICTED ON OURSELVES DUE TO YOUR SYRINGES. JABBING OURSELF 10,20,30 TIMES SWAPPING TO NEW ONES IN THE PROCESS. HOW CAN YOU LET BAD BATCHES LIKE THIS OUT TO THE PUBLIC .? IT¿S EMBARRASSING IT¿S DISGUSTING IT¿S DRAINING AND STRESSFUL , BUT I BET YOUR JUST THINKING ¿ OH WE¿LL JUST ANOTHER JUNKY¿ WE ARE CLEAN RESPECTFUL LAW ABIDING PEOPLE AND USING YOUR SYRINGES HAS MADE US FEEL LIKE JUNKIES , WHICH WE ARE NOT . WE ARE THAT DISGUSTED AND UPSET BY THIS THAT WE ARE CONSIDERING SEEING A LAWYER, WE HAVE TAKEN PHOTOS OF OUR ARMS AND THE NEEDLES JUST IN CASE WE DECIDE TO SEEK LEGAL ADVICE . WE BELIEVE YOU ARE LIABLE FOR THE DAMAGE DONE DUE TO YOUR FAULTY SYRINGES. I WONDER HOW MANY OTHER PEOPLE THIS HAS AFFECTED. I LOOK FORWARD TO YOUR REPLY THANK YOU **NAME REMOVED.**

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD¿ TUBERCULIN SYRINGE THE PLUNGER WAS LOOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD COMPANY , MY PARTNER AND I ARE INTRAVENOUS DRUG USERS AND HAVE BEEN FOR A LONG TIME , AND NEVER IN OUR WHOLE TIME AS USERS HAVE WE EVER HAD AN ISSUE WITH YOUR 1ML SYRINGES UNTIL RECENTLY. WE HAD A BATCH OF YOUR SYRINGES THAT WERE FAULTY IN A MAJOR WAY, THEY CAUSED SO MUCH DAMAGE TO OUR ARMS AND VEINS DUE TO THE PLUNGER BEING TO LOSE, IT WOULDN¿T JACK BACK SO WE CONSTANTLY THOUGHT THE NEEDLE WASN¿T IN. WE DIDN¿T REALISE IT WAS THE NEEDLES UNTIL WE WENT AND GOT DIFFERENT ONES FROM SOMEWHERE ELSE. YOU HAVE NO IDEA THE DAMAGE WE HAVE INFLICTED ON OURSELVES DUE TO YOUR SYRINGES. JABBING OURSELF 10,20,30 TIMES SWAPPING TO NEW ONES IN THE PROCESS. HOW CAN YOU LET BAD BATCHES LIKE THIS OUT TO THE PUBLIC .? IT¿S EMBARRASSING IT¿S DISGUSTING IT¿S DRAINING AND STRESSFUL , BUT I BET YOUR JUST THINKING ¿ OH WELL JUST ANOTHER JUNKY¿ WE ARE CLEAN RESPECTFUL LAW ABIDING PEOPLE AND USING YOUR SYRINGES HAS MADE US FEEL LIKE JUNKIES , WHICH WE ARE NOT . WE ARE THAT DISGUSTED AND UPSET BY THIS THAT WE ARE CONSIDERING SEEING A LAWYER, WE HAVE TAKEN PHOTOS OF OUR ARMS AND THE NEEDLES JUST IN CASE WE DECIDE TO SEEK LEGAL ADVICE . WE BELIEVE YOU ARE LIABLE FOR THE DAMAGE DONE DUE TO YOUR FAULTY SYRINGES. I WONDER HOW MANY OTHER PEOPLE THIS HAS AFFECTED. I LOOK FORWARD TO YOUR REPLY THANK YOU **NAME REMOVED**.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125785 BD¿ TUBERCULIN SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown