BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II INSULIN SYRINGE

    MDR report key: 8169822 · Received December 17, 2018

    Report

    Report Number
    1920898-2018-00934
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    November 28, 2018
    Report Date
    December 11, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF SHELF CARTONS OF 1CC, 8MM, 31G SYRINGES WITH THE SHIPPING CARTONS FROM LOT # 7345823. CUSTOMER STATES THAT THE PRINTING IS MISSING ON THE SHELF CARTON. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED MISSING LOT NUMBER, MANUFACTURING DATE, AND EXPIRATION DATE INFORMATION ON THE SHELF CARTONS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7345823. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. INVESTIGATION CONCLUSION: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE DESCRIPTION: POTENTIAL ROOT CAUSE IS THE BOX MAY HAVE BEEN FED INCORRECTLY DURING STAMPING OF THE INFORMATION REQUIRED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGED BD ULTRA-FINE¿ II INSULIN SYRINGES WERE MISSING LABEL CONTENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008872 BD ULTRA-FINE¿ II INSULIN SYRINGE SYRINGE FMF BD MEDICAL - DIABETES CARE 7345823

    Patients

    Seq Age Sex Outcome Treatment
    1 Other