BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ LUER SLIP-TIP SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 15587903 · Received October 12, 2022

    Report

    Report Number
    1213809-2022-00702
    Event Type
    Malfunction
    Date Received
    October 12, 2022
    Date of Event
    August 24, 2022
    Report Date
    October 10, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096268
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER PHONE#: UNKNOWN. FDA NOTIFIED?: THE INITIAL REPORTER ALSO NOTIFIED THE FDA VIA MEDWATCH #MW 5111856. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. 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 THAT THE NEEDLE OF THE BD¿ LUER SLIP-TIP SYRINGE WITH ATTACHED NEEDLE BROKE OFF INTO THE PATIENT'S ARM DURING THE MEDICINE ADMINISTRATION. NO FURTHER INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: :BD TB SYRINGES DO NOT HAVE SAFETY NEEDLE. NEEDLE CAN COME UNATTACHED DURING ADMINISTRATION OF MEDICATION. DURING ADMINISTRATION THE NEEDLE CAME OFF SYRINGE, LEAVING NEEDLE IN THE PATIENT ARM. THIS CAUSED AN INCREASED RISK OF STAFF NEEDLE STICK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2743730 BD¿ LUER SLIP-TIP SYRINGE WITH ATTACHED NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 00382903096268

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown