BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 9521446 · Received December 26, 2019

    Report

    Report Number
    1920898-2019-01472
    Event Type
    Malfunction
    Date Received
    December 26, 2019
    Date of Event
    December 10, 2019
    Report Date
    January 9, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311762
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (1) 1/2CC, 8MM, 31G RELION SYRINGE IN AN OPEN POLY BAG FROM LOT # 9070565. CUSTOMER STATES THAT THEY TOOK THE SHIELD OFF AND NEEDLE HUB ASSEMBLY STAYED WITHIN THE 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# 9070565. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200812808, 200812871] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION [200813047] NOTED FOR CRACKED HUBS. THERE WERE NO NOTIFICATIONS OR MAINTENANCE DISPATCHES DURING THE TIMEFRAME OF THIS BATCH THAT PERTAIN TO THIS DEFECT. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE HUB SEPARATED FROM THE RELION® INSULIN SYRINGE DURING USE WHEN REMOVING THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1 SYRINGE TOOK SHIELD OFF AND NEEDLE HUB ASSEMBLY STAYED WITHIN THE SHIELD."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: N/A. 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 THE NEEDLE HUB SEPARATED FROM THE RELION® INSULIN SYRINGE DURING USE WHEN REMOVING THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1 SYRINGE TOOK SHIELD OFF AND NEEDLE HUB ASSEMBLY STAYED WITHIN THE SHIELD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317102 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328509 9070565 00681131311762

    Patients

    Seq Age Sex Outcome Treatment
    1 Other