BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2243072-2017-00019

    MDR report key: 6419686 · Received March 20, 2017

    Report

    Report Number
    2243072-2017-00019
    Event Type
    Injury
    Date Received
    March 20, 2017
    Date of Event
    February 23, 2017
    Report Date
    February 24, 2017
    PMA / PMN Number
    K991088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY THE MANUFACTURER IS USED. (B)(4). MANUFACTURING LOCATION: (B)(4), IS USED AS THE MANUFACTURING SITE. THE ACTUAL MANUFACTURING SITE FOR THIS DEVICE IS AN OEM IN (B)(4). DEVICE MANUFACTURE DATE: RESULT - A SAMPLE WAS NOT RETURNED FOR EVALUATION. EVALUATION OF 50 RETENTION SAMPLES OF THE REPORTED LOT WERE CHECK VISUALLY FOR ABNORMALITY SUCH AS DAMAGE, MOLDING DEFECT, ETC. ON THE SAFETY SHIELDS. NO ABNORMALITY WAS FOUND. THE BREAKAWAY FORCE, SUSTAINING FORCE AND SECURITY FORCE OF THE SAFETY SHIELDS WAS MEASURED FOR 13 SETS AND NO ABNORMALITY WAS FOUND. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER. CONCLUSION - THE MANUFACTURING SITE COULD NOT CONFIRM THE CUSTOMER'S INDICATED FAILURE AS NO SAMPLES WERE RETURNED FOR EVALUATION. NO DEFECTS WERE NOTED IN EVALUATION OF THE RETENTION SAMPLES. PER THE MANUFACTURING SITE: "UNDER OUR MANUFACTURING PROCESS, INCOMING INSPECTION IS CONDUCTED FOR MOLDED PARTS AND ONLY LOT PASSED THE INSPECTION IS USED FOR ASSEMBLY, THEREFORE, THE POSSIBILITY THAT A DEFECTIVE PART IS ASSEMBLED TO PRODUCT IS VERY LOW. ALSO, PRODUCT IS ASSEMBLED BY AUTOMATIC ASSEMBLY MACHINES AND ROUTINE MAINTENANCE CHECK IS CONDUCTED FOR THE MACHINES, THEREFORE, THE POSSIBILITY THAT THE DEFECT IS CAUSED BY MACHINES IS VERY LOW. IN ADDITION, PRODUCTS ARE SAMPLED PER 2 HOURS AND THE APPEARANCE, DIMENSION AND FUNCTION ARE CHECKED UNDER PROCESS INSPECTION AND THE SAME CHECK IS PERFORMED UNDER RELEASE INSPECTION, THEREFORE, THE DEFECT COULD BE DETECTED IF BY ANY CHANCE THE DEFECT IS CAUSED BY MACHINES CONTINUOUSLY DUE TO A MACHINE TROUBLE OR SOMETHING."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY SHEATH FAILED TO DEPLOY OVER THE NEEDLE OF THE SUSPECT DEVICE, RESULTING IN A NEEDLE STICK INJURY TO THE EMPLOYEE.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other