BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18GA 2IN

    MDR report key: 12162791 · Received July 13, 2021

    Report

    Report Number
    3002682307-2021-00320
    Event Type
    Malfunction
    Date Received
    July 13, 2021
    Date of Event
    June 14, 2021
    Report Date
    August 23, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 201029 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. AS SAMPLES WERE UNAVAILABLE FOR RETURN, OUR QUALITY TEAM OBTAINED TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER FROM THE MANUFACTURING FACILITY FOR FURTHER EVALUATION. NONE OF THE SAMPLES DISPLAYED SIGNS OF CLOGGING. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE IDENTIFIED FOR THIS INCIDENT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE 18GA 2IN WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OCCLUDED NEEDLE. UNABLE TO ASPIRATE DRUGS THRU THE NEEDLE. POTENTIALLY OCCLUDED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE 18GA 2IN WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OCCLUDED NEEDLE. UNABLE TO ASPIRATE DRUGS THRU THE NEEDLE. POTENTIALLY OCCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056666 NEEDLE 18GA 2IN NEEDLE FMI BECTON DICKINSON, S.A. 201029

    Patients

    Seq Age Sex Outcome Treatment
    1