BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II 3/10ML INSULIN SYRINGE

    MDR report key: 16369150 · Received February 13, 2023

    Report

    Report Number
    1920898-2023-00048
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    January 23, 2023
    Report Date
    June 15, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903266388
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, 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: 14-FEB-2023 H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (11) SYRINGE 0.3ML 30GA 8MM AND ONE EMPTY OPEN POLYBAG FROM THE LOT# 2031535 IN A CLEAR ZIPLOCK BAG. THE CUSTOMER REPORTED THAT LIQUID WAS FOUND IN THE BARREL. THE RETURN SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR ANY FLUID BY PUSHING THE SYRINGE PLUNGER AND OBSERVED NO FLUID OR ANY OTHER ISSUES. HENCE, THE ALLEGED ISSUE COULD NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2031535. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE SAMPLE RECEIVED, EMBECTA WAS NOT ABLE TO CONFIRM THE CUSTOMER INDICATED ISSUE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ II 3/10ML INSULIN SYRINGE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: AN ANIMAL OWNER REPORTED THAT A LIQUID WAS FOUND IN THE BARREL. THIS ISSUE WAS OBSERVED IN ONE OR TWO SYRINGES IN A POLYBAG CONTAINING 7 PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ II 3/10ML INSULIN SYRINGE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: AN ANIMAL OWNER REPORTED THAT A LIQUID WAS FOUND IN THE BARREL. THIS ISSUE WAS OBSERVED IN ONE OR TWO SYRINGES IN A POLYBAG CONTAINING 7 PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2229192 BD ULTRA-FINE¿ II 3/10ML INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2031535 00382903266388

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown