BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 15135819 · Received July 29, 2022

    Report

    Report Number
    1920898-2022-00495
    Event Type
    Malfunction
    Date Received
    July 29, 2022
    Date of Event
    June 30, 2022
    Report Date
    July 5, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K212499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: CUSTOMER RETURNED (497) 3/10CC, 8MM, 31G SYRINGES (7 IN AN OPEN POLY BAG, 490 IN SEALED POLY BAGS) IN THE SHELF CARTONS, IN THE SHIPPING CARTON FROM LOT # 1221832. CUSTOMER STATES THAT THEY WERE NOT ABLE TO DRAW INTO THE SYRINGE. ALL SAMPLES FROM THE OPEN POLY BAG AS WELL AS 30 SAMPLES FROM THE SEALED POLY BAGS WERE TESTED AND ALL WERE ABLE TO DRAW AND EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1221832. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA/SA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLE WERE UNABLE TO ASPIRATE THE MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NOT ABLE TO DRAW INTO THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1903514 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1221832

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown