BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2243072-2017-00056

    MDR report key: 6679340 · Received June 29, 2017

    Report

    Report Number
    2243072-2017-00056
    Event Type
    Injury
    Date Received
    June 29, 2017
    Date of Event
    June 8, 2017
    Report Date
    August 30, 2017
    PMA / PMN Number
    K991088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RETAINED SAMPLES OF THE LOT CONCERNED 50 SETS WERE CHECKED VISUALLY AND NO ABNORMALITY SUCH AS DAMAGE, MOLDING DEFECT, ETC. ON SAFETY SHIELDS, WHICH COULD BE RELATED TO THE REPORTED EVENT, WAS FOUND. ALSO, EACH ACTUATION OF SAFETY SHIELDS OF THE LOT CONCERNED 13 SETS WAS CHECKED AND NO PROBLEM WAS FOUND ON THE BREAKAWAY FORCE, SUSTAINING FORCE OR SECURITY FORCE. ALSO, THE MANUFACTURING AND INSPECTION RECORDS OF THE LOT CONCERNED WERE REVIEWED AND NO ABNORMALITY WHICH COULD BE RELATED TO THE REPORTED EVENT WAS FOUND. THE REPORTED EVENT WAS NOT CONFIRMED AT OUR PLANT. SINCE NO ACTUAL SAMPLE WAS RECEIVED AND OUR SAFETY SHIELD DOES NOT HAVE ANY PLACE TO BE CAUGHT STRUCTURALLY, IT WAS UNABLE TO SPECIFY THE CAUSE OF THE REPORTED EVENT UNFORTUNATELY. 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. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHLEBOTOMIST HAD A NEEDLE STICK INJURY AFTER USE WITH A 23 G X 0.75 IN NEEDLE X 12 IN TUBING BD SAFETY-LOK BLOOD COLLECTION AND INFUSION SET WITH LUER ADAPTER. IT WAS REPORTED THAT MEDICAL INTERVENTION WAS PROVIDED BUT THE DETAILS OF THE INTERVENTION ARE UNKNOWN.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other