BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE NS 23GA 1-1/2IN FLT GRD

    MDR report key: 9083489 · Received September 18, 2019

    Report

    Report Number
    1911916-2019-00980
    Event Type
    Malfunction
    Date Received
    September 18, 2019
    Date of Event
    September 3, 2019
    Report Date
    September 24, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE (1) PHOTO WAS PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE PHOTO SHOWS A SPOT ON A GRAY SURFACE WHICH HAS BEEN CIRCLED IN A RED CIRCLE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEW DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. WITHOUT A PHYSICAL SAMPLE TO ANALYZE THE SPOT IN THE PHOTO CANNOT BE IDENTIFIED; THEREFORE, POTENTIAL ROOT CAUSES CANNOT BE DETERMINED, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE PROPOSED IN THE SCOPE OF THIS COMPLAINT. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE NS 23GA 1-1/2IN FLT GRD EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECT DETECTED DURING PREPARATION FOR USE IN THE PROCESS.

    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 THE NEEDLE NS 23GA 1-1/2IN FLT GRD EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECT DETECTED DURING PREPARATION FOR USE IN THE PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878829 NEEDLE NS 23GA 1-1/2IN FLT GRD HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 9004967

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other