BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE 0.3ML 0.30MM X 8MM

    MDR report key: 16502854 · Received March 8, 2023

    Report

    Report Number
    1920898-2023-00098
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    February 9, 2023
    Report Date
    March 17, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. THE CUSTOMER RETURNED THREE PHOTOS OF THE 30GX8MM POLYBAGS FROM LOT 2173943. THE CUSTOMER REPORTED POLYBAG TORN AND LACK OF INFORMATION. THE PHOTOS WERE EXAMINED, AND IT WAS OBSERVED THAT THE POLYBAG IS TORN DOWN THE BACK OF THE POUCH. ANOTHER PHOTO REVEALS THE LOT NUMBER, EXPIRATION DATE AND MANUFACTURER DATE MISSING FROM THE POLYBAG. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2173943. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE PHOTOS RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MISSING LABEL CONTENT (LOT NUMBER, MANUFACTURER DATE AND EXPIRATION DATE MISSING) A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE 0.3ML 0.30MM (30G) X 8MM (5/16") U-100 HAD MISSING LABEL INFORMATION. IT WAS REPORTED THAT 400 WERE AFFECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MISSING INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE 0.3ML 0.30MM (30G) X 8MM (5/16") U-100 HAD MISSING LABEL INFORMATION. IT WAS REPORTED THAT 400 WERE AFFECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MISSING INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136282 BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE 0.3ML 0.30MM X 8MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2173943

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown