BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETY-LOK¿ SYRINGE WITH NEEDLE

    MDR report key: 7806489 · Received August 22, 2018

    Report

    Report Number
    1213809-2018-00570
    Event Type
    Malfunction
    Date Received
    August 22, 2018
    Date of Event
    August 7, 2018
    Report Date
    September 18, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903095933
    PMA / PMN Number
    K944757
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. INVESTIGATION SUMMARY: THREE LOOSE 3ML ASSEMBLED SAFETY-LOK SYRINGES IN 2 BAGS WERE RECEIVED AND REPORTED TO BE FROM BATCH #8122576 (P/N 309593). THE SAMPLES WERE VISUALLY EVALUATED. SAMPLE BAG #1 ¿ TWO SYRINGES. ONE SYRINGE HAD A NEEDLE ATTACHED WITH THE SAFETY SLEEVE ACTIVATED. THE NEEDLE IS NOT A CANAAN COMPONENT THAT IS SUPPLIED WITH THIS PRODUCT. THE SECOND SYRINGE DID NOT HAVE A NEEDLE ATTACHED. BOTH SYRINGES WERE INSPECTED FOR DAMAGE OR SIGNS OF LEAKAGE. NO DEFECTS WERE OBSERVED. SAMPLE BAG #2 ¿ ONE SYRINGE WITH ¿LIDOCAINE HCL¿ LABEL ATTACHED AND ONE LOOSE NEEDLE. THE NEEDLE HUB WAS WRAPPED IN TAPE. THE NEEDLE IS NOT A CANAAN COMPONENT THAT IS SUPPLIED WITH THIS PRODUCT. THE SYRINGE HAD NO DAMAGE OR SIGNS OF LEAKAGE. THE ONE SYRINGE WITHOUT THE LABEL FROM SAMPLE BAG 1 WAS TESTED FOR LEAKAGE AT LUER. A BD 21G X 1¿ NEEDLE WAS ATTACHED TO THE SYRINGE FOR THE TEST. WATER WAS ASPIRATED TO NOMINAL CAPACITY OF THE SYRINGE. IT WAS THEN EXPELLED THROUGH THE NEEDLE. NO LEAKAGE WAS OBSERVED. PROBABLE ROOT CAUSE: THE REPORTED DEFECT WAS NOT CONFIRMED TO BE ASSOCIATED WITH THE SAFETY-LOK PRODUCT. IT IS IMPORTANT TO NOTE THE NEEDLE SUPPLIED WITH THE PRODUCT WAS CHANGED. THEREFORE, IT IS POSSIBLE THE REPORTED DEFECT IS ASSOCIATED WITH THAT CHANGE. NO CORRECTIVE ACTIONS RECOMMENDED SINCE PRODUCT DEFECT WAS NOT CONFIRMED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SAFETY-LOK¿ SYRINGE WITH NEEDLE LEAKED AT THE LUER CONNECTION. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD SAFETY-LOK¿ SYRINGE WITH NEEDLE LEAKED AT THE LUER CONNECTION. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645621 BD SAFETY-LOK¿ SYRINGE WITH NEEDLE SYRINGE AND NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 8122576 00382903095933

    Patients

    Seq Age Sex Outcome Treatment
    1 Other