BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION® INSULIN SYRINGE

    MDR report key: 14940324 · Received July 6, 2022

    Report

    Report Number
    1920898-2022-00433
    Event Type
    Malfunction
    Date Received
    July 6, 2022
    Date of Event
    June 7, 2022
    Report Date
    July 28, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131138376
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED A SINGLE 0.5ML SYRINGE. VISUAL INSPECTION OF THE SYRINGE FOUND A CRACK IN THE SYRINGE¿S SURFACE RUNNING DOWN THE BARREL OF THE SYRINGE FROM ROUGHLY THE (B)(4) TO (B)(4) UNIT MARKERS. ADDITIONALLY, WATER WAS FOUND TO LEAK THROUGH THIS CRACK WHEN ATTEMPTING TO DRAW FLUID INTO THE BARREL OF THE SYRINGE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1242742. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF LEAKAGE. A ROOT-CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RELION® INSULIN SYRINGE WAS CRACKED AND LEAKED INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOUND 1 SYRINGE WITH A CRACK IN THE BARREL OF SYRINGE WHILE DRAWING UP INSULIN. FOUND INSULIN TO WET HER HAND."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RELION® INSULIN SYRINGE WAS CRACKED AND LEAKED INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOUND 1 SYRINGE WITH A CRACK IN THE BARREL OF SYRINGE WHILE DRAWING UP INSULIN. FOUND INSULIN TO WET HER HAND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2722710 RELION® INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1242742 00681131138376

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown