BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE WITH STERILE INTERIOR

    MDR report key: 13621033 · Received February 28, 2022

    Report

    Report Number
    1920898-2022-00132
    Event Type
    Malfunction
    Date Received
    February 28, 2022
    Date of Event
    February 15, 2022
    Report Date
    March 4, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED AN IMAGE OF A SHELF CARTON AND SEVERAL POLYBAGS FOR 1ML, 31 GAUGE, 6MM SYRINGES FROM LOT 1200866. THE RESOLUTION AND DETAILS OF THE IMAGE ARE NOT SUFFICIENT TO DIRECTLY CONFIRM ANY ISSUES WITH THE INFORMATION PRINTED ON THE SHELF CARTON OR POLYBAGS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1200866. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE IMAGE RECEIVED, BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF A PACKAGE PRINTING DEFECT. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 100 BD ULTRA-FINE¿ INSULIN SYRINGES WITH STERILE INTERIOR HAD LABEL INFORMATION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE VENDOR LOT NUMBER AND EXPIRATION DATE ARE NOT CLEAR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 100 BD ULTRA-FINE¿ INSULIN SYRINGES WITH STERILE INTERIOR HAD LABEL INFORMATION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE VENDOR LOT NUMBER AND EXPIRATION DATE ARE NOT CLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883212 BD ULTRA-FINE¿ INSULIN SYRINGE WITH STERILE INTERIOR PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1200866

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown