BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30GA 1/2IN

    MDR report key: 8615820 · Received May 16, 2019

    Report

    Report Number
    3002682307-2019-00308
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    April 29, 2019
    Report Date
    May 30, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SINCE BD WAS UNABLE TO DUPLICATE OR REPRODUCE YOUR INDICATED FAILURE MODE BECAUSE NO SAMPLE HAS BEEN PROVIDED, NEITHER WHICH SYRINGE WAS USED AND REVIEW OF DHR SHOW NO ABNORMALITIES DURING NEEDLES MANUFACTURING, A DEFINITIVE ROOT CAUSE RELATED NEEDLE MANUFACTURING PROCESS IS NOT POSSIBLE TO DETERMINE, AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE 30GA 1/2IN EXPERIENCED A DEFECTIVE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE INFORM YOU THAT WE HAVE RECEIVED A NEW CUSTOMER COMPLAINT FOR A NEEDLE ("THE PATIENT REPORTS THAT THE SMALLER NEEDLE DID NOT FIT INTO THE SYRINGE AND HAD TO CUT THE SIDE WITH A KNIFE"). LOT SUPPLIER: 180319, REF: 304000). THE SAMPLE OF THE CLAIM IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE 30GA 1/2IN EXPERIENCED A DEFECTIVE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE INFORM YOU THAT WE HAVE RECEIVED A NEW CUSTOMER COMPLAINT FOR A NEEDLE ("THE PATIENT REPORTS THAT THE SMALLER NEEDLE DID NOT FIT INTO THE SYRINGE AND HAD TO CUT THE SIDE WITH A KNIFE"). LOT SUPPLIER: 180319, REF: (B)(4). THE SAMPLE OF THE CLAIM IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407715 NEEDLE 30GA 1/2IN NEEDLE FMI BECTON DICKINSON, S.A. 180319

    Patients

    Seq Age Sex Outcome Treatment
    1 Other