THE DISTRIBUTOR REPORTED THAT?NURSE?(B)(6) ((B)(6) HOSPITAL),?INDICATED THAT?DURING COMPLICATIONS IN A CHILD OF THREE YEARS, WITH HEIGHT AND WEIGHT APPROPRIATE TO THE AGE AT THE TIME OF?USE OF THE PRODUCT TO PERFORM INTRAOSSEOUS INFUSION, THERE WAS SOME DIFFICULTY IN PENETRATION; HOWEVER, THE PROCEDURE?PROGRESSED AND THE PATIENT?WAS GIVEN THE NECESSARY INFUSION. THE CLINICIAN?REALIZED THAT DURING THE PROCEDURE, THE INFUSION OF DRUGS WAS?DIFFICULT / SLOW. AFTER THE END OF THE COMPLICATION WHEN THEY PULLED THE NEEDLE FROM THE PATIENT, THEY?REALIZED THAT IT WAS CROOKED, THUS LEADING TO THE CONCLUSION THAT PERHAPS THIS FACT IS WHAT MADE THE?MEDICATION?INFUSE WITH DIFFICULTY?DURING THE PROCEDURE. IT WAS INDICATED THAT THE LOT NUMBER INFORMATION WAS NOT AVAILABLE?AS DURING A CHILD EMERGENCY,?THE PRIORITY IS THE WELFARE AND CARE, NOT ADMINISTRATIVE INFORMATION. ON (B)(6) 2013, THE CUSTOMER ((B)(6)), PROVIDED THE FOLLOWING ADDITIONAL INFORMATION:?THE PATIENT ARRIVED WITH CARDIAC ARREST AND THE PRODUCT WAS USED FOR INFUSION OF DRUGS IN AN ATTEMPT TO REVIVE THE PATIENT.?THERE WAS NOTHING NOTED OF THE NEEDLE PRIOR TO USE THAT WOULD INDICATE A DEFECT. THIS WAS THE FIRST TIME THIS PHYSICIAN USED THE PRODUCT AND THE PHYSICIAN DID EXPERIENCE SOME DIFFICULTY INSERTING THE NEEDLE. IT IS UNKNOWN IF THE NEEDLE WAS?INSERTED AT A 90 DEGREE ANGLE TO THE BONE. THE PATIENT'S CURRENT STATUS IS DECEASED.
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Patient 1
(B)(4). THE REPORTED CONDITION COULD NOT BE CONFIRMED AS THE SAMPLE HAS NOT BEEN RECEIVED AS OF YET. A REVIEW OF APPLICABLE MANUFACTURING, INSPECTION, AND PACKAGING PROCEDURES DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. SPECIFICALLY, THE MANUFACTURING PROCEDURES REQUIRE VERIFICATION OF THE CONDITION OF MATERIAL PRIOR TO USE IN THE PRODUCTION OF EACH NEEDLE. IN ADDITION, INSPECTION PROCEDURES REQUIRE PERSONNEL TO PERFORM MULTIPLE VISUAL AND FUNCTIONAL TESTS PRIOR TO RELEASING THE PRODUCT. THE DESCRIPTION OF THE INCIDENT ALSO SPECIFIES THAT THERE WAS NOTHING NOTED OF THE NEEDLE PRIOR TO USE THAT WOULD INDICATE A DEFECT AND DURING A REVIEW OF THE MANUFACTURING PROCESS NO ISSUES WERE FOUND THAT COULD RELATE PERSONNEL TO THE REPORTED CONDITION. A REVIEW OF THE INTERNAL PRODUCTION RECORDS FOR THE LOT INVOLVED COULD NOT BE PERFORMED AS LOT NUMBER INFORMATION WAS NOT PROVIDED. THE MOST PROBABLE ROOT CAUSE COULD NOT BE DETERMINED AS NO ISSUES WERE FOUND DURING REVIEW OF THE APPLICABLE MANUFACTURING AND PACKAGING PROCESSES THAT COULD RELATE PERSONNEL OR MANUFACTURING METHOD TO THE REPORTED CONDITION. THE MANUFACTURING PLANT IS CONTINUING TO MONITOR THIS ISSUE TO IDENTIFY THE NEED FOR ANY FURTHER ACTIONS. WHEN/IF THE SAMPLE IS RECEIVED FOR EVALUATION, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE SAMPLE EVALUATION.
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Patient 1
(B)(4). BASED ON THE ACTUAL SAMPLE INVOLVED RECEIVED FOR EVALUATION, INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED FOR EVALUATION. ONLY THE OUTER CANNULA WAS RECEIVED; NEITHER THE STYLET NOR THE CAP WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION, IT WAS NOTED THAT THE OUTER CANNULA WAS BENT; NO BURRS WERE NOTED IN THE OUTER CANNULA TIP. DIMENSIONAL TESTING WAS PERFORMED FINDING THAT THE OUTER DIAMETER OF THE CANNULA WAS 0.0495 INCHES AND THE INNER DIAMETER OF THE CANNULA WAS 0.0330 INCHES. (B)(4). THEREFORE, NO ISSUES WERE NOTED WITH THE DIMENSIONS OF THE SAMPLE SUBMITTED FOR EVALUATION. THE BENT CONDITION REPORTED WAS CONFIRMED; HOWEVER, ALTHOUGH THE BENT CONDITION COULD CONTRIBUTE TO A SLOW INFUSION OF MEDICATION DURING THE PROCEDURE, THE SLOW FLOW REPORTED COULD NOT BE CONFIRMED. THE DESCRIPTION OF THE EVENT NOTES THAT NO DEFECT WAS NOTED OF THE UNIT PRIOR TO USE; THEREFORE, THE BENT CONDITION THAT OCCURRED DURING THE PROCEDURE COULD HAVE CAUSED THE SLOW FLOW REPORTED. ALTHOUGH THERE IS NO EVIDENCE THAT THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT WERE NOT FOLLOWED PROPERLY, THE DESCRIPTION OF THE INCIDENT DOES NOT SPECIFY THE ANGLE TO WHICH THE STEADY PRESSURE AND TWISTING MOTION WERE APPLIED. SECTION THREE (3) OF THE IFU OF THE INTRAOSSEOUS TECHNIQUE IS CRITICAL TO THE PROPER USE OF THE DEVICE. IT PROVIDES DETAILS ABOUT THE POSITIONING OF THE NEEDLE PERPENDICULAR TO THE BONE (90 DEGREES) FOR APPROPRIATE INSERTION. A REVIEW OF APPLICABLE MANUFACTURING, INSPECTION, AND PACKAGING PROCEDURES DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. SPECIFICALLY, THE MANUFACTURING PROCEDURES REQUIRE VERIFICATION OF THE CONDITION OF MATERIAL PRIOR TO USE IN THE PRODUCTION OF EACH NEEDLE. IN ADDITION, INSPECTION PROCEDURES REQUIRE PERSONNEL TO PERFORM MULTIPLE VISUAL AND FUNCTIONAL TESTS PRIOR TO RELEASING THE PRODUCT. THE DESCRIPTION OF THE INCIDENT ALSO SPECIFIES THAT THERE WAS NOTHING NOTED OF THE NEEDLE PRIOR TO USE THAT WOULD INDICATE A DEFECT AND DURING A REVIEW OF THE MANUFACTURING PROCESS NO ISSUES WERE FOUND THAT COULD RELATE PERSONNEL TO THE REPORTED CONDITION. A REVIEW OF THE INTERNAL PRODUCTION RECORDS FOR THE LOT INVOLVED COULD NOT BE PERFORMED AS LOT NUMBER INFORMATION WAS NOT PROVIDED. THE MOST PROBABLE ROOT CAUSE COULD NOT BE DETERMINED AS NO ISSUES WERE FOUND DURING REVIEW OF THE APPLICABLE MANUFACTURING AND PACKAGING PROCESSES THAT COULD RELATE PERSONNEL, MANUFACTURING METHOD, OR MATERIALS USED TO THE REPORTED CONDITION. THE MANUFACTURING PLANT IS CONTINUING TO MONITOR THIS ISSUE TO IDENTIFY THE NEED FOR ANY FURTHER ACTIONS.