BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 15801900 · Received November 15, 2022

    Report

    Report Number
    1920898-2022-00803
    Event Type
    Malfunction
    Date Received
    November 15, 2022
    Date of Event
    September 21, 2022
    Report Date
    November 30, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908421010
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1095063. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BROWN FOREIGN MATTER WAS FOUND ON THE BD ULTRA-FINE¿ INSULIN SYRINGE NEEDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE PATIENT'S RIGHT EYE HAD MACULAR EDEMA. ON SEPTEMBER 21, OCULAR INJECTION WAS PERFORMED TO REDUCE THE OCCURRENCE OF EDEMA AND IMPROVE THE PATIENT'S VISION. WITH THIS SINGLE-USE STERILE INSULIN SYRINGE INJECTION, YOU CAN REDUCE THE USE OF VALUABLE DRUG RESIDUES. WHEN THE MEDICAL STAFF OPENED THE PACKAGE AND WAS ABOUT TO EXTRACT THE MEDICINE, THEY FOUND A BROWN FOREIGN BODY ON THE NEEDLE, SO THEY MARKED IT, REPLACED ONE, AND COMPLETED THE OPERATION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BROWN FOREIGN MATTER WAS FOUND ON THE BD ULTRA-FINE¿ INSULIN SYRINGE NEEDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE PATIENT'S RIGHT EYE HAD MACULAR EDEMA. ON SEPTEMBER 21, OCULAR INJECTION WAS PERFORMED TO REDUCE THE OCCURRENCE OF EDEMA AND IMPROVE THE PATIENT'S VISION. WITH THIS SINGLE-USE STERILE INSULIN SYRINGE INJECTION, YOU CAN REDUCE THE USE OF VALUABLE DRUG RESIDUES. WHEN THE MEDICAL STAFF OPENED THE PACKAGE AND WAS ABOUT TO EXTRACT THE MEDICINE, THEY FOUND A BROWN FOREIGN BODY ON THE NEEDLE, SO THEY MARKED IT, REPLACED ONE, AND COMPLETED THE OPERATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171764 BD ULTRA-FINE¿ INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1095063 00382908421010

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown