BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MICROFINE PLUS INSULIN SYRINGE

    MDR report key: 8458065 · Received March 27, 2019

    Report

    Report Number
    1920898-2019-00285
    Event Type
    Injury
    Date Received
    March 27, 2019
    Date of Event
    March 4, 2019
    Report Date
    April 8, 2019
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD MICROFINE¿ PLUS INSULIN SYRINGE NEEDLE BROKE OFF INTO THE PATIENT'S VEIN DURING THE INJECTION OF HEROIN, REQUIRING "MEDICAL CARE" TO REMOVE. HOWEVER, THE TYPE OF MEDICAL INTERVENTION WAS NOT SPECIFIED BY THE CUSTOMER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A CLIENT COMPLAINED THAT A NEEDLE OF BD INSULIN SYRINGE (REF 320931) BROKE DURING INJECTION AND STAYED IN VEIN, THEREFORE MEDICAL CARE WAS REQUIRED. THE NEEDLE BROKE AT THE CONNECTION TO A PLASTIC SYRINGE. THE SYRINGE WAS USED BY THE DRUG ADDICTED PERSON FOR INJECTION OF HEROIN. INVESTIGATION SUMMARY: CUSTOMER RETURNED (100) 1CC, 12.7MM, 29G SYRINGES IN SEALED POLY BAGS WITH THE SHELF CARTON FROM LOT # 7233914. CUSTOMER STATES THAT THE NEEDLE BROKE DURING INJECTION AND STAYED IN THE VEIN. THIRTY OUT OF 100 RETURNED SYRINGES WERE EXAMINED AND NO BENT OR BROKEN CANNULA OR ANY OTHER DEFECTS WERE OBSERVED ON THESE SYRINGES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7233914. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200711382, 200712187] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROFINE¿ PLUS INSULIN SYRINGE NEEDLE BROKE OFF INTO THE PATIENT'S VEIN DURING THE INJECTION OF HEROIN, REQUIRING "MEDICAL CARE" TO REMOVE. HOWEVER, THE TYPE OF MEDICAL INTERVENTION WAS NOT SPECIFIED BY THE CUSTOMER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A CLIENT COMPLAINED THAT A NEEDLE OF BD INSULIN SYRINGE (REF 320931) BROKE DURING INJECTION AND STAYED IN VEIN, THEREFORE MEDICAL CARE WAS REQUIRED. THE NEEDLE BROKE AT THE CONNECTION TO A PLASTIC SYRINGE. THE SYRINGE WAS USED BY THE DRUG ADDICTED PERSON FOR INJECTION OF HEROIN.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD MICROFINE¿ PLUS INSULIN SYRINGE NEEDLE BROKE OFF INTO THE PATIENT'S VEIN DURING THE INJECTION OF HEROIN, REQUIRING "MEDICAL CARE" TO REMOVE. HOWEVER, THE TYPE OF MEDICAL INTERVENTION WAS NOT SPECIFIED BY THE CUSTOMER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A CLIENT FROM NATIONAL INSTITUTE OF PUBLIC HEALTH COMPLAINED THAT A NEEDLE OF BD INSULIN SYRINGE (REF (B)(4)) BROKE DURING INJECTION AND STAYED IN VEIN, THEREFORE MEDICAL CARE WAS REQUIRED. THE NEEDLE BROKE AT THE CONNECTION TO A PLASTIC SYRINGE. THE SYRINGE WAS USED BY THE DRUG ADDICTED PERSON FOR INJECTION OF HEROIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248162 BD MICROFINE PLUS INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 7233914

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention