BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18GA 1-1/2IN SB TW

    MDR report key: 10371038 · Received August 5, 2020

    Report

    Report Number
    3002682307-2020-00240
    Event Type
    Malfunction
    Date Received
    August 5, 2020
    Date of Event
    July 15, 2020
    Report Date
    August 27, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 7/30/2020. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 200419 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS INCIDENT, BOTH PHYSICAL AND PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UNFORTUNATELY, THE PHYSICAL SAMPLES COULD NOT BE LOCATED BY OUR PLANT'S INVESTIGATIVE TEAM; HOWEVER, THE PICTURE PROVIDED WAS SUFFICIENT FOR A COMPLETE INVESTIGATION. THROUGH EXAMINATION OF THE PICTURE, EMBEDDED BURNT PARTICLES WERE OBSERVED WITHIN THE SHIELD. DURING THE MOLDING PROCESS, TEMPERATURES ARE HIGH AND IF THE GASES ARE NOT PROPERLY EXPELLED, BURNT PARTICLES CAN REMAIN WITHIN THE MOLDING CAVITY. THIS IS A COSMETIC DEFECT WHICH POSES NO RISK TO HEALTH AS THE PARTICLES ARE EMBEDDED WITHOUT THE POSSIBILITY OF DETACHMENT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE 18GA 1-1/2IN SB TW HAD RUST/STAINING. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE/PROTECTION SHOWS TRACES OF RUST / STAINING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE 18 GA 1-1/2 IN SB TW HAD RUST/STAINING. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE/PROTECTION SHOWS TRACES OF RUST / STAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831158 NEEDLE 18GA 1-1/2IN SB TW NEEDLE FMI BECTON DICKINSON, S.A. 200419

    Patients

    Seq Age Sex Outcome Treatment
    1 Other