BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MICRO-FINE¿+ PEN NEEDLE

    MDR report key: 15180108 · Received August 5, 2022

    Report

    Report Number
    9616656-2022-00817
    Event Type
    Injury
    Date Received
    August 5, 2022
    Date of Event
    July 8, 2022
    Report Date
    August 18, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    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: 10-AUG-2022. H.6. INVESTIGATION SUMMARY: TWO OPEN 31G X 5MM PEN NEEDLE SAMPLES AND FOUR PHOTOS WERE RETURNED FROM LOT. NO. 1243863, CAT. NO. 320129. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND PHOTOS AND A BROKEN NON PATIENT END OF CANNULA ON WAS OBSERVED ON ONE SAMPLE. NO ISSUES WERE OBSERVED WITH THE REMAINING SAMPLE. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. AS THE CONFIRMED SAMPLE WAS RETURNED OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MICRO-FINE¿+ PEN NEEDLE BROKE OFF, AND COULD NOT BE FOUND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT A NEEDLE PE BREAKING OFF, WHICH COULD NOT BE FOUND ANYWHERE, WAS MISSING AFTER INJECTION. THE PATIENT UNDERWENT AN ULTRASOUND TEST IN THE HOSPITAL, WHICH DID NOT DETECT THE NEEDLE IN THE BODY. IT HAS BEEN REPORTED THAT THERE IS NO PROBLEM WITH THE PATIENT'S HEALTH CONDITIONS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MICRO-FINE¿+ PEN NEEDLE BROKE OFF, AND COULD NOT BE FOUND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT A NEEDLE PE BREAKING OFF, WHICH COULD NOT BE FOUND ANYWHERE, WAS MISSING AFTER INJECTION. THE PATIENT UNDERWENT AN ULTRASOUND TEST IN THE HOSPITAL, WHICH DID NOT DETECT THE NEEDLE IN THE BODY. IT HAS BEEN REPORTED THAT THERE IS NO PROBLEM WITH THE PATIENT'S HEALTH CONDITIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689132 BD MICRO-FINE¿+ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1243863

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention