BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD STERILE INSULIN SYRINGE

    MDR report key: 8617711 · Received May 16, 2019

    Report

    Report Number
    1920898-2019-00459
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    February 1, 2019
    Report Date
    May 24, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    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: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 6060630. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200643226, 200644523] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STERILITY IS COMPROMISED DUE TO SEAL INTEGRITY WITH A BD¿ STERILE INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: IT WAS FOUND GAS LEAKED FROM THE UNIT PACKAGE WHEN CHECKING THE SEAL OF THE PACKAGE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STERILITY IS COMPROMISED DUE TO SEAL INTEGRITY WITH A BD¿ STERILE INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: IT WAS FOUND GAS LEAKED FROM THE UNIT PACKAGE WHEN CHECKING THE SEAL OF THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408233 BD STERILE INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 6060630

    Patients

    Seq Age Sex Outcome Treatment
    1 Other