BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30GA 1/2IN

    MDR report key: 8725578 · Received June 23, 2019

    Report

    Report Number
    3002682307-2019-00375
    Event Type
    Malfunction
    Date Received
    June 23, 2019
    Date of Event
    June 5, 2019
    Report Date
    July 2, 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

    H.6. INVESTIGATION: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 304000 LOT 180319 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. SINCE DEFECT IS NOT CONFIRMED AND REVIEW OF DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT, NO CORRECTIVE ACTION ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE 30GA 1/2IN EXPERIENCED THE NEEDLE AND SYRINGE SEPARATING/SPINNING OUT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLE IS EXPELLED WHEN TRYING TO MAKE THE APPLICATION OF THE PRODUCT". IMPACTED 30G NEEDLE SET: 18080056 (LOT SUPPLIER: 180319, REFERENCE: 304000). ACCORDING TO THE DESCRIPTION, I THINK THAT THE NEEDLE DETACHED FROM THE SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THE NEEDLE AND SYRINGE SEPARATING/SPINNING OUT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLE IS EXPELLED WHEN TRYING TO MAKE THE APPLICATION OF THE PRODUCT" IMPACTED 30G NEEDLE SET: 18080056 (LOT SUPPLIER: 180319, REFERENCE: 304000). ACCORDING TO THE DESCRIPTION, I THINK THAT THE NEEDLE DETACHED FROM THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519226 NEEDLE 30GA 1/2IN NEEDLE FMI BECTON DICKINSON, S.A. 180319

    Patients

    Seq Age Sex Outcome Treatment
    1 Other