BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE WITH STERILE INTERIOR

    MDR report key: 14383171 · Received May 12, 2022

    Report

    Report Number
    1920898-2022-00330
    Event Type
    Malfunction
    Date Received
    May 12, 2022
    Date of Event
    April 23, 2022
    Report Date
    May 25, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    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: CUSTOMER RETURNED AN IMAGE OF A POLYBAG FOR 0.3ML, 31 GAUGE, 6MM SYRINGES FROM LOT 1242715. THE PRINT FOR THE LOT NUMBER, MANUFACTURING DATE, AND EXPIRATION DATE ARE DISPLACED MULTIPLE CENTIMETERS TO THE RIGHT OF THE INTENDED LOCATION, RESULTING IN THE TEXT OVERLAPPING WITH THE POLYBAG¿S BAR CODE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #1242715 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, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF A PRINTING DEFECT ON THE POLYBAG. NO ROOT CAUSE COULD BE DETERMINED.

    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 : IT WAS REPORTED THAT VENDOR LOT AND EXPIRY DATE ARE NOT CLEAR ON POLY BAG.

    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: IT WAS REPORTED THAT VENDOR LOT AND EXPIRY DATE ARE NOT CLEAR ON POLY BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580475 BD ULTRA-FINE¿ INSULIN SYRINGE WITH STERILE INTERIOR ANTI-STICK SYRINGE MEG BD MEDICAL - DIABETES CARE 1242715

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown