BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BECTON DICKINSON AND CO.

    MDR report key: 8341331 · Received February 14, 2019

    Report

    Report Number
    1047429-2019-00003
    Event Type
    Injury
    Date Received
    February 14, 2019
    Date of Event
    January 18, 2019
    Report Date
    February 14, 2019
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AVID MEDICAL IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY ((B)(4), LOT# 1340776) THAT INCLUDES THE FOLLOWING COMPONENT: NDL, 25G X 1.5" RG BEV BLU HB, VENDOR PART #303018 MANUFACTURED BY BECTON DICKINSON AND CO. AVID MEDICAL RECEIVED A COMPLAINT ON (B)(6) 2019 ORIGINATED BY (B)(6) - SPECIAL PROCEDURES LAB, (B)(6) MEDICAL CENTER STATING THAT THE NEEDLE BROKE IN HALF WHILE PERFORMING A HIP INJECTION PROCEDURE. THE COMPLAINED NDL, 25G X 1.5" RG BEV BLU HB PART WAS NOT AVAILABLE FOR EVALUATION. AVID MEDICAL ISSUED FORMAL COMPLAINT # (B)(4) TO THE MANUFACTURER BECTON DICKINSON AND CO (REG: (B)(4)) CONCERNING THE 303018, MANUFACTURER LOT# 8531998. ORTHOPEDICS EXAMINED THE NEEDLE BREAK AND FOUND THE SITUATION WAS NOT HARMFUL TO THE PATIENT AND LEFT THE NEEDLE IN PLACE AT THAT TIME. THE NEEDLE PORTION WAS LATER REMOVED BY A DIFFERENT PHYSICIAN FROM ANOTHER FACILITY, THESE DETAILS ARE UNKNOWN. THE PATIENT HAD NO ADVERSE EFFECTS ASSOCIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134958 BECTON DICKINSON AND CO. HYPODERMIC NEEDLE PRECISIONGLIDE FMI 303018 8531998

    Patients

    Seq Age Sex Outcome Treatment
    1 Other