BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD¿ NEEDLE

    MDR report key: 17358179 · Received July 20, 2023

    Report

    Report Number
    2243072-2023-01273
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    June 21, 2023
    Report Date
    August 10, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY : AS NO PHYSICAL SAMPLE, VALID PART NUMBER OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD¿ NEEDLE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT REPORTED HAVING TROUBLE WITH DRAWING MEDICINE INTO THE NEEDLE AND THINKS THAT THE PROBLEM IS THE RUBBER TOP ON THE VIAL OF THE MEDICINE AND NOT THE NEEDLE. PATIENT IS A FORMER ICU NURSE AND VERY WELL VERSED IN INJECTIONS AND SAYS THAT A LONGER NEEDLE WOULD HAVE NO TROUBLE GETTING MEDICATION OUT. PATIENT WASTED ONE DOSE WHEN MEDICINE LEAKED OUT AND WENT ALL OVER HIS HAND, SO HE IS NEEDING A REPLACEMENT DOSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD¿ NEEDLE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT REPORTED HAVING TROUBLE WITH DRAWING MEDICINE INTO THE NEEDLE AND THINKS THAT THE PROBLEM IS THE RUBBER TOP ON THE VIAL OF THE MEDICINE AND NOT THE NEEDLE. PATIENT IS A FORMER ICU NURSE AND VERY WELL VERSED IN INJECTIONS AND SAYS THAT A LONGER NEEDLE WOULD HAVE NO TROUBLE GETTING MEDICATION OUT. PATIENT WASTED ONE DOSE WHEN MEDICINE LEAKED OUT AND WENT ALL OVER HIS HAND, SO HE IS NEEDING A REPLACEMENT DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146763 UNSPECIFIED BD¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown