BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 9833938 · Received March 16, 2020

    Report

    Report Number
    1920898-2020-00249
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Date of Event
    February 21, 2020
    Report Date
    March 18, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908411035
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED ONE (1) 30GX12.7MM, 1ML BD INSULIN SYRINGE FROM AN OPENED POLYBAG FROM LOT 9140662. CONSUMER REPORTED: INSULIN LEAKED INTO THE BLACK AREA OF SYRINGE PAST THE PLUNGER STOPPER AND INTO THE ROD SECTION OF SYRINGE; CONSUMER ALSO REPORTED THE EXPIRATION DATE IS 2024-06-31 WHEN THERE IS NO CALENDAR DAY OF JUNE 31, 2024. THE RETURNED POLYBAG WAS EXAMINED, AND IT WAS OBSERVED THAT THE EXPIRATION DATE CORRECTLY DISPLAYED 2024-05-31 (LOT 9140662 WAS MANUFACTURED ON 2019-05-20 SO A FIVE YEAR SHELF LIFE PUTS THE EXPIRATION DATE AT 2024-05-31). THE RETURNED SYRINGE WAS EXAMINED, THEN TESTED FOR FLOW: THE SYRINGE WAS ABLE TO DRAW AND EXPEL PROPERLY, AND NO LEAKAGE WAS OBSERVED. SINCE NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED, THE ALLEGED ISSUES COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9140662. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328411 BATCH NO: 9140662. IT WAS REPORTED THAT THE INSULIN LEAKED INTO THE BLACK AREA OF SYRINGE- PAST THE PLUNGER STOPPER AND INTO THE ROD SECTION OF SYRINGE, ADDING THAT THE EXPIRATION DATE IS 2024-06-31 WHEN THERE IS NO CALENDAR DAY OF JUNE 31, 2024. VERBATIM: CONSUMER REPORTED # 1 INSULIN LEAKED INTO THE BLACK AREA OF SYRINGE- PAST THE PLUNGER STOPPER AND INTO THE ROD SECTION OF SYRINGE. CONSUMER REPORTED # 2 THE EXPIRATION DATE IS 2024-06-31 WHEN THERE IS NO CALENDAR DAY OF JUNE 31, 2024.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328411 BATCH NO: 9140662. IT WAS REPORTED THAT THE INSULIN LEAKED INTO THE BLACK AREA OF SYRINGE- PAST THE PLUNGER STOPPER AND INTO THE ROD SECTION OF SYRINGE, ADDING THAT THE EXPIRATION DATE IS 2024-06-31 WHEN THERE IS NO CALENDAR DAY OF JUNE 31, 2024. VERBATIM: CONSUMER REPORTED # 1 INSULIN LEAKED INTO THE BLACK AREA OF SYRINGE- PAST THE PLUNGER STOPPER AND INTO THE ROD SECTION OF SYRINGE. CONSUMER REPORTED # 2 THE EXPIRATION DATE IS 2024-06-31 WHEN THERE IS NO CALENDAR DAY OF JUNE 31, 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300203 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328411 9140662 00382908411035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other