BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE W STERILE INTERIOR 1ML 0,25MM (31G) X 6MM

    MDR report key: 17183270 · Received June 22, 2023

    Report

    Report Number
    1920898-2023-00379
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Date of Event
    May 30, 2023
    Report Date
    September 14, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 23-JUN-2023. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) 1ML 31GA 6MM SYRINGES LOOSE. WHEN THE DRUG IS MEASURED, THE HUB IS BROKEN, AND THERE ARE A LOT OF AIR BUBBLES IN THE BARREL. THE RETURNED SYRINGES WERE VISUALLY INSPECTED AND LOOKS LIKE THE TIP(EDGE) OF THE HUB WAS CHIPPED OFF/MELTED. FUNCTIONALITY TEST WAS PERFORMED, AND NO ISSUES WERE OBSERVED WITH FLOW AND AIR BUBBLES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2199495. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE RETURN SAMPLES, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER INDICATED ISSUE. NO ROOT CAUSE HAS BEEN DETERMINED. PROBABLE ROOT CAUSE: L2L DISPATCH FOR DAMAGED BARRELS. 153498: BARREL LOADER CONVEYOR BROKEN WINGS, CAUSING DAMAGED BARRELS. 153560, 153537: OVEN JAM/DAMAGED BARRELS. 153515: BR PRINTER DAMAGING BARRELS H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ASPIRATION WITH BD ULTRA-FINE¿ INSULIN SYRINGE WITH STERILE INTERIOR 1ML 0,25MM (31G) X 6MM THE HUB WAS DISCOVERED TO BE BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE DRUG IS MEASURED, THE HUB IS BROKEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ASPIRATION WITH BD ULTRA-FINE¿ INSULIN SYRINGE WITH STERILE INTERIOR 1ML 0,25MM (31G) X 6MM THE HUB WAS DISCOVERED TO BE BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE DRUG IS MEASURED, THE HUB IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80728 BD ULTRA-FINE¿ INSULIN SYRINGE W STERILE INTERIOR 1ML 0,25MM (31G) X 6MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2199495

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown