BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ PLUS INSULIN SYRINGE

    MDR report key: 7786318 · Received August 15, 2018

    Report

    Report Number
    1920898-2018-00627
    Event Type
    Malfunction
    Date Received
    August 15, 2018
    Date of Event
    July 24, 2018
    Report Date
    August 24, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE OF THE BD MICRO-FINE¿ PLUS INSULIN SYRINGE BROKE DURING THE INJECTION OF HEROIN AND REMAINED INSIDE THE USER'S VEIN. THERE WAS NO REPORT OF EXPOSURE OR MEDICAL INTERVENTION NOTED.

    Additional Manufacturer Narrative · 1

    (B)(6). INVESTIGATION SUMMARY: CUSTOMER RETURNED (6) 1CC, 12.7MM, 29G SYRINGES IN AN OPEN POLY BAG FROM LOT # 7142920. CUSTOMER STATES THAT THE BROKE DURING THE INJECTION AND STAYED IN THE VEIN. ALL RETURNED SYRINGES WERE EXAMINED AND NO BENT OR BROKEN CANNULA WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7142920. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. 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. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE OF THE BD MICRO-FINE¿ PLUS INSULIN SYRINGE BROKE DURING THE INJECTION OF HEROIN AND REMAINED INSIDE THE USER'S VEIN. THERE WAS NO REPORT OF EXPOSURE OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627104 BD MICRO-FINE¿ PLUS INSULIN SYRINGE SYRINGE FMF BD MEDICAL - DIABETES CARE 7142920

    Patients

    Seq Age Sex Outcome Treatment
    1 Other