BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 7300625 · Received February 27, 2018

    Report

    Report Number
    1920898-2018-00077
    Event Type
    Malfunction
    Date Received
    February 27, 2018
    Date of Event
    February 6, 2018
    Report Date
    February 7, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION: CUSTOMER RETURNED (3) 1CC, 6MM, 31G SYRINGES IN AN OPEN POLY BAG FROM LOT # 5243890. CUSTOMER STATES THAT WHEN THE MEDICINE IS APPLIED TO THE SUBCUTANEOUS TISSUE THE PLUNGER LOCKS AND IT IS NECESSARY TO APPLY TOO MUCH FORCE, GENERATING PAIN IN THE PATIENT. ALL RETURNED SYRINGES WERE TESTED AND ALL WERE ABLE TO DRAW AND EXPEL WITHOUT ANY OBSERVED DEFECTS. ALL SAMPLES WERE ALSO TESTED FOR POINT GEOMETRY, LUBE, AND CANNULA OD. THE FOLLOWING WAS OBSERVED (SPECS: OUTER DIAMETER FOR 31G: 0.0100¿-0.0105¿): (B)(6). ALL OBSERVATIONS FALL WITHIN SPECIFICATIONS. AS PER MANUFACTURING, A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 5243890. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED, THE INVESTIGATION BD 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLUNGER ON A BD ULTRA-FINE¿ INSULIN SYRINGE IS DIFFICULT TO MOVE AND INCREASED FORCE IS NECESSARY TO ADMINISTER THE MEDICATION. CUSTOMER STATES THIS IS CAUSING PAIN ALTHOUGH THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144960 BD ULTRA-FINE¿ INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 5243890

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other