BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 7412330 · Received April 10, 2018

    Report

    Report Number
    1920898-2018-00208
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    March 22, 2018
    Report Date
    March 26, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER ADDRESS: (B)(6). INVESTIGATION: LEVEL A INVESTIGATION. CUSTOMER RETURNED (3) LOOSE 3/10CC, 6MM SYRINGES ALL FILLED WITH APPROXIMATELY 8 UNITS OF A CLOUDY LIQUID INSIDE THE BARREL. CUSTOMER STATES THAT THE PLUNGER WASN¿T ABLE TO BE PUSHED DOWN. ALL RETURNED SYRINGES WERE TESTED AND ALL PLUNGER RODS WERE ABLE TO BE DEPRESSED WITHOUT ANY OBSERVED DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7023681 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FOUR (4) NOTIFICATIONS (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: - UNCONFIRMED: 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 ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER DRAWING UP INSULIN INTO MULTIPLE BD INSULIN SYRINGE(S) WITH BD ULTRA-FINE¿ NEEDLE, THE PLUNGER WAS DIFFICULT TO PRESS DOWN NOT ALLOWING MEDICATION TO BE ADMINISTERED. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253806 BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE 7023681 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other