BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEN NEEDLE 31GX5MM 5B 28CT

    MDR report key: 10834213 · Received November 13, 2020

    Report

    Report Number
    3006948883-2020-00742
    Event Type
    Injury
    Date Received
    November 13, 2020
    Date of Event
    October 20, 2020
    Report Date
    November 18, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FMI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: DHR AND MANUFACTURE RECORDS WERE REVIEWED, NO ABNORMALITY WAS FOUND. INSPECTED 7PCS RETENTION SAMPLE CANNULA ANGLE, CANNULA APPEARANCE AND CANNULA PULL FORCE. ALL RESULTS PASSED. NO SAMPLES OR PHOTOS WERE RETURNED FOR ANALYSIS. COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PEN NEEDLE 31GX5MM 5B 28CT EXPERIENCED THE CANNULA BREAKING OFF/PULLING OUT. A PORTION OF THE CANNULA BECAME EMBEDDED WITHIN THE PATIENT. AS A RESULT, THE PATIENT RECEIVED MEDICAL INTERVENTION IN THE FORM OF AN XRAY SCREEN. THE EMBEDDED PORTION OF THE CANNULA WAS NOT FOUND. NO ADDITIONAL INFORMATION REGARDING THE PATIENT'S OUTCOME IS CURRENTLY AVAILABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE WAS BROKEN IN THE PATIENT'S BODY WHEN HE WAS INJECTING INSULIN ON THE MORNING OF 10/20. THE PRODUCT WAS XINYOURUI 0.25*5MM, LOT NUMBER 0042783, ARTICLE NUMBER 239496,AFTER CHECKING, THERE WAS NO BENDING, AND THEY WERE NOT SURE IF IT WAS DISPOSABLE COMMUNICATE WITH THE CUSTOMER, THE USER IS AN ELDERLY PERSON, AND THE X-RAY HAS BEEN MADE SO FAR. THE X-RAY DID NOT SEE THE NEEDLE IN THE BODY. THE SAMPLE HAS BEEN DISCARDED AND CANNOT BE RETRIEVED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEN NEEDLE 31GX5MM 5B 28CT EXPERIENCED THE CANNULA BREAKING OFF/PULLING OUT. A PORTION OF THE CANNULA BECAME EMBEDDED WITHIN THE PATIENT. AS A RESULT, THE PATIENT RECEIVED MEDICAL INTERVENTION IN THE FORM OF AN XRAY SCREEN. THE EMBEDDED PORTION OF THE CANNULA WAS NOT FOUND. NO ADDITIONAL INFORMATION REGARDING THE PATIENT'S OUTCOME IS CURRENTLY AVAILABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE WAS BROKEN IN THE PATIENT'S BODY WHEN HE WAS INJECTING INSULIN ON THE MORNING OF 10/20. THE PRODUCT WAS XINYOURUI 0.25*5MM, LOT NUMBER 0042783, ARTICLE NUMBER (B)(4), AFTER CHECKING, THERE WAS NO BENDING, AND THEY WERE NOT SURE IF IT WAS DISPOSABLE COMMUNICATE WITH THE CUSTOMER, THE USER IS AN ELDERLY PERSON, AND THE X-RAY HAS BEEN MADE SO FAR. THE X-RAY DID NOT SEE THE NEEDLE IN THE BODY. THE SAMPLE HAS BEEN DISCARDED AND CANNOT BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300749 PEN NEEDLE 31GX5MM 5B 28CT PEN NEEDLE FMI BD (SUZHOU) 0042783

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention