BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE INSULIN SYRINGE

    MDR report key: 7366800 · Received March 23, 2018

    Report

    Report Number
    1920898-2018-00173
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Date of Event
    March 15, 2018
    Report Date
    April 25, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903294169
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    CORRECTION: CONTACT INFORMATION HAS BEEN UPDATED. INVESTIGATION SUMMARY: CUSTOMER RETURNED FOUR LOOSE 1CC SYRINGE. CUSTOMER STATES THAT THE SYRINGE WAS LEAKING. ALL RETURNED SYRINGES WERE EXAMINED AND ALL WERE ABLE TO DRAW AND EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7241532. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITH USE A BD¿ ULTRA-FINE INSULIN SYRINGE WAS FOUND LEAKING. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211001 BD ULTRA-FINE INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7241532 00382903294169

    Patients

    Seq Age Sex Outcome Treatment
    1 Other