BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NEEDLE 1/2 IN. SINGLE USE, STERILE, 30 G

    MDR report key: 16053249 · Received December 27, 2022

    Report

    Report Number
    1911916-2022-00778
    Event Type
    Malfunction
    Date Received
    December 27, 2022
    Date of Event
    December 7, 2022
    Report Date
    January 4, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER FACILITY NAME: THE OHIO STATE UNIVERSITY WEXNER MEDICAL CENTER AND THE JAMES CANCER HOSPITAL A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305106 AND LOT NUMBER 2020896. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ NEEDLE 1/2 IN. SINGLE USE, STERILE, 30 G EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR FACULTY COMMENTED THAT WE HAD TO DISCARD A SYRINGE OF EYLEA (EXPENSIVE MEDICATION) DUE TO LIQUID LEAKING WHERE THE NEEDLE MEETS THE HUB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ NEEDLE 1/2 IN. SINGLE USE, STERILE, 30 G EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR FACULTY COMMENTED THAT WE HAD TO DISCARD A SYRINGE OF EYLEA (EXPENSIVE MEDICATION) DUE TO LIQUID LEAKING WHERE THE NEEDLE MEETS THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445480 BD¿ NEEDLE 1/2 IN. SINGLE USE, STERILE, 30 G HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 2020896 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown