BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 0.3ML 31GA 6MM

    MDR report key: 9794616 · Received March 5, 2020

    Report

    Report Number
    1920898-2020-00210
    Event Type
    Malfunction
    Date Received
    March 5, 2020
    Date of Event
    February 14, 2020
    Report Date
    April 2, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249091
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (1) LOOSE 3/10CC SYRINGE. CUSTOMER STATES THAT THE NEEDLE SHIELD DIFFICULT TO REMOVE BEFORE INJECTION AND ALSO NEEDLE HUB SEPARATED AND STAYED IN SHIELD. THE SYRINGE WAS RETURNED WITH THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9252570. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200845676, 200845565] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WERE TWO (2) NOTIFICATIONS [200845567, 200845495] NOTED FOR HIGH SHIELD PULL. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 0.3ML, SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. DHR, L2L DISPATCHES, AND LOGBOOK ENTRIES WERE LOOKED AT, NOTHING PERTAINING TO THIS DEFECT WAS FOUND. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA#1122103 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE HUB SEPARATED AND STAYED IN SHIELD WITH A BD SYRINGE 0.3ML 31GA 6MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NEEDLE HUB SEPARATED AND STAYED IN SHIELD.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE HUB SEPARATED AND STAYED IN SHIELD WITH A BD SYRINGE 0.3ML 31GA 6MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NEEDLE HUB SEPARATED AND STAYED IN SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259161 BD SYRINGE 0.3ML 31GA 6MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324909 9252570 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other