BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 9355181 · Received November 21, 2019

    Report

    Report Number
    1920898-2019-01308
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    November 4, 2019
    Report Date
    November 27, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131138383
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: CUSTOMER RETURNED ONE (1) 31GX6MM, 0.3ML RELION INSULIN SYRINGE IN AN OPENED POLYBAG FROM LOT 9133810. CUSTOMER REPORTED WHEN SHE REMOVED THE NEEDLE SHIELD, NEEDLE DETACHED WITH THE HUB AND REMAINED IN THE NEEDLE SHIELD. THE RETURNED SYRINGE WAS EXAMINED, AND NO EVIDENCE OF NEEDLE-HUB/SHIELD ASSEMBLY SEPARATION WAS OBSERVED. SINCE NO MANUFACTURING DEFECTS WERE OBSERVED, THE ALLEGED ISSUE COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #9133810. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED FOR CRACKED HUBS.

    Description of Event or Problem · 1

    MATERIAL NO. 328521, BATCH NO. 9133810. IT WAS REPORTED THAT DURING USE OF THE RELION® INSULIN SYRINGE WHEN REMOVING THE NEEDLE SHIELD, THE HUB SEPARATED INTO THE NEEDLE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PET OWNER REPORTED WHEN SHE REMOVED THE NEEDLE SHIELD, NEEDLE DETACHED WITH THE HUB AND REMAINED IN THE NEEDLE SHIELD.

    Description of Event or Problem · 1

    MATERIAL NO. 328521 BATCH NO. 9133810. IT WAS REPORTED THAT DURING USE OF THE RELION® INSULIN SYRINGE WHEN REMOVING THE NEEDLE SHIELD, THE HUB SEPARATED INTO THE NEEDLE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PET OWNER REPORTED WHEN SHE REMOVED THE NEEDLE SHIELD, NEEDLE DETACHED WITH THE HUB AND REMAINED IN THE NEEDLE SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154496 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9133810 00681131138383

    Patients

    Seq Age Sex Outcome Treatment
    1 Other