BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE 30G X 5MM

    MDR report key: 5799239 · Received July 15, 2016

    Report

    Report Number
    9616656-2016-00043
    Event Type
    Injury
    Date Received
    July 15, 2016
    Date of Event
    June 25, 2016
    Report Date
    July 27, 2016
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K110703
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: SAMPLES HAVE BEEN RECEIVED FOR EVALUATION. ON THE ACTUAL SAMPLE, IT WAS NOTED THAT THE SAFETY MECHANISM WAS NOT ACTIVATED AND THE PATIENT END OF THE NEEDLE IS SLIGHTLY OUT. THE SAMPLES WERE SENT TO THE MANUFACTURE SITE FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RESULT - BD RECEIVED 12 PHOTOS, 41 SEALED AND 3 OPENED 30GX5MM PEN NEEDLE SAMPLES FROM THE REPORTED CATALOG 329705, LOT 5210805. ONE OF THE OPENED SAMPLES WAS THE ACTUAL DEVICE SAMPLE. A VISUAL EXAMINATION OF THE OPENED SAMPLES WAS CARRIED OUT. IT WAS OBSERVED THAT THE FIRST SAMPLE WAS ACTIVATED CORRECTLY. THE SECOND SAMPLE HAD THE INNER SHIELD ONLY PARTIALLY PRESSED INTO THE SLEEVE. THE THIRD SAMPLE WAS NOT ACTIVATED. DURING ACTIVATION TEST ON THE SECOND AND THIRD OPENED SAMPLES, NO ISSUES WERE OBSERVED. ACTIVATION TEST WAS ALSO CARRIED OUT ON 30 OF THE SEALED SAMPLES AND NO ISSUES WERE OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER 5210805 WAS CARRIED OUT. CALIBRATED CRITICAL PROCESS SETTINGS WERE REVIEWED AND NO ISSUES WERE OBSERVED. OPERATOR PROCESS INSPECTIONS WERE REVIEWED AND NO ISSUES WERE OBSERVED. QA IN-PROCESS INSPECTIONS WERE REVIEWED AND NO ISSUES WERE OBSERVED. FINAL INSPECTIONS WERE REVIEWED AND NO ISSUES WERE FOUND. A REVIEW OF THE MAINTENANCE LOG FOR THE ASSEMBLY LINE SHOWED NO MAINTENANCE WHICH COULD HAVE INFLUENCED THIS FAIL MODE WAS PERFORMED ON THE LINES DURING PRODUCTION OF THIS LOT. CONCLUSION - BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE. ACTIVATION TEST PERFORMED SHOWED NO ISSUES. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016 AT 11:30 AM THE NURSE WAS GIVING THE PATIENT AN INJECTION USING THE SUSPECT DEVICE. THE SAFETY SHIELD FAILED TO ACTIVATE COMPLETELY AND THE NURSE SUSTAINED A NEEDLE STICK INJURY. THE NURSE RECEIVED INFECTIOUS DISEASE TESTING AND ALL RESULTS WERE (B)(6). THE PATIENT DOES NOT HAVE A KNOWN INFECTIOUS DISEASE. PER REPORT, THE NURSE STARTED WORKING IN THAT POSITION IN (B)(6) 2016, HAD NOT BEEN VACCINATED, AND HAS ONLY USED THE BD AUTOSHIELD SAFETY DUO A FEW TIMES. IT WAS ALSO NOTED THAT ON THE DATE OF THE INCIDENT, THERE WERE INSUFFICIENT HEALTHCARE PRACTITIONERS WORKING SO THERE WAS POSSIBLY A LACK OF ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452294 BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE 30G X 5MM PEN NEEDLE FMI BECTON DICKINSON AND CO. 5210805

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention