BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 10107386 · Received June 1, 2020

    Report

    Report Number
    1024879-2020-00367
    Event Type
    Malfunction
    Date Received
    June 1, 2020
    Date of Event
    May 18, 2020
    Report Date
    May 28, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMF
    UDI-DI
    00681131138383
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. INVESTIGATION SUMMARY: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE HUB MISSING ON LOT # 9231343. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #9231343. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE TWO (2) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HUB WAS MISSING WHEN NEEDLE SHIELD WAS REMOVED WITH A RELION® INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE HUB IS COMPLETELY MISSING FROM THE SYRINGE. CONSUMER DISCARDED THE SHIELD, BUT HAS JUST THE BARREL PART OF THE SYRINGE. CONSUMER DOES NOT KNOW IF HUB ASSEMBLY WAS WITHIN THE NEEDLE SHIELD BUT NOTED THIS SYRINGE WAS NOT USABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571233 RELION INSULIN SYRINGE PISTON SYRINGE FMF BECTON, DICKINSON & CO., (BD) 328521 9231343 00681131138383

    Patients

    Seq Age Sex Outcome Treatment
    1 Other