BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGES

    MDR report key: 16773332 · Received April 19, 2023

    Report

    Report Number
    1920898-2023-00243
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Date of Event
    March 30, 2023
    Report Date
    July 13, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908468039
    PMA / PMN Number
    K212499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 08-MAY-2023. H6: INVESTIGATION SUMMARY: THE CUSTOMER RETURNED (1) 0.5ML 31GA 8MM SYRINGE, REPORTING FOREIGN MATTER IN THE SYRINGE. THE SYRINGE WAS VISUALLY INSPECTED AND OBSERVED NO PHYSICAL DAMAGES. THE SYRINGE WAS TESTED BY PUSHING THE PLUNGER AND NO MATERIAL CAME OUT OF THE CANNULA. BASED ON THE SAMPLE RETURNED, EMBECTA WAS NOT ABLE TO CONFIRM THE CUSTOMER-INDICATED FAILURE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2213872. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THE ROOT CAUSE CANNOT BE DETERMINED, AS THE REPORTED FAILURE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RELION INSULIN SYRINGES HAS FOREIGN MATTER WITHIN THE FLUID PATH. THIS IS 1 OF 2 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THERE IS LIQUID IN THE SYRINGES, HE STATED THAT WHEN DEPRESSES THE PLUNGER ROD, LIQUID COMES OUT OF THE SYRINGE. CONSUMER ALSO REPORTED THAT THE PLUNGER ROD IS DIFFICULT TO MOVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RELION INSULIN SYRINGES HAS FOREIGN MATTER WITHIN THE FLUID PATH. THIS IS 1 OF 2 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THERE IS LIQUID IN THE SYRINGES, HE STATED THAT WHEN DEPRESSES THE PLUNGER ROD, LIQUID COMES OUT OF THE SYRINGE. CONSUMER ALSO REPORTED THAT THE PLUNGER ROD IS DIFFICULT TO MOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1600495 RELION INSULIN SYRINGES PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328468 2213872 00382908468039

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown