BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE¿ DETACHABLE NEEDLE

    MDR report key: 12776439 · Received November 9, 2021

    Report

    Report Number
    1213809-2021-00757
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 11, 2021
    Report Date
    October 19, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096238
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF BIRTH: PATIENT¿S BIRTHDAY WAS NOT PROVIDED, 1931-01-01 WAS USED BASED ON AGE OF PATIENT. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD¿ TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE¿ DETACHABLE NEEDLE, THE DEVICE EXPERIENCED LEAKAGE AT THE CONNECTION SITE, AND CONNECTIVITY ISSUES WHEN THE NEEDLE SPUN OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE LAST FEW PRESCRIPTIONS I'VE GOTTEN SEEMED THAT THEY WERE VERY FRAGILE AND I HAD TO BE CAREFUL THAT THE NEEDLE DIDN'T SEPARATE FROM THE SYRINGE PART. THE OTHER DAY I FILLED THE NEEDLE, INJECTED IT INTO MY LEG AND PUSHED THE PLUNGER. THE SOLUTION CAME OUT ABOVE THE NEEDLE AND RAN ALL OVER MY LEG. A SOLUTION AND NEEDLE WASTED AND NO SHOT FOR ME. TODAY I TRIED AGAIN BUT COULDN'T REMOVE THE COVER ON THE NEEDLE ON TWO NEEDLES. I ONLY HAVE 3. WHEN I TRIED TO REMOVE THE COVER I ONLY SUCCEED TO SEPARATE THE TWO PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676754 BD¿ TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE¿ DETACHABLE NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309623 UNKNOWN 30382903096238

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Female