BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE

    MDR report key: 16164876 · Received January 13, 2023

    Report

    Report Number
    1920898-2023-00006
    Event Type
    Malfunction
    Date Received
    January 13, 2023
    Date of Event
    December 26, 2022
    Report Date
    January 27, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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. SEVERAL IMAGES OF THE 30GX8MM BD SYRINGE WERE PROVIDED. THE CUSTOMER REPORTED SPOTTED BOXES. THE IMAGES WERE EXAMINED, AND IT WAS OBSERVED THAT PHOTO APPEARS TO HAVE SOME SORT OF SPOT OR TEAR ON THE SHELF CARTON. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2052365. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE IMAGES RECEIVED, EMBECTA WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF PACKING PRINTING DEFECT. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. BASED ON THE IMAGES RECEIVED, EMBECTA WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF PACKING PRINTING DEFEC.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE LABEL INFORMATION HAD BEEN REMOVED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPOTTED BOX

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE LABEL INFORMATION HAD BEEN REMOVED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPOTTED BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018637 BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2052365

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown