Description of Event or Problem · 1
IT WAS REPORTED VIA RECEIPT OF ATTORNEY CORRESPONDENCE THAT A CLINICIAN AT HOSPITAL, SUSTAINED "INJURIES... WHILE UTILIZING A NEEDLE MANUFACTURED BY ICU MEDICAL, INC., SPECIFICALLY A PUNCTURE GUARD WINGED SET." THE MANUFACTURER WAS NOTIFIED AS A RESULT OF AN INSURANCE/DISABILITY CLAIM REVIEW. LIMITED INFORMATION PROVIDED/AVAILABLE REGARDING THE INCIDENT, THE DEVICE AND THE NATURE OF THE INJURY. IT IS ALLEGED THAT "THE BLOOD VIAL BROKE AND SOMETHING MALFUNCTIONED ON THE NEEDLE". IT IS UNKNOWN WHAT TYPE OF PROCEDURE AND OR APPLICATION WAS BEING ATTEMPTED AND/OR IF THERE WERE ANY CONTRIBUTING CIRCUMSTANCES, I.E. WHETHER THE PT WAS COMBATIVE, UNCOOPERATIVE. IT IS ALSO UNKNOWN WHAT TYPE OF INJURY WAS SUSTAINED AT THE TIME OF THE INCIDENT, AND OR WHAT MEDICAL INTERVENTION, TREATMENT (S) MAY HAVE OCCURRED ETC. THIS REPORT IS BEING SUBMITTED AS A CAUTIONARY MEASURE AND DOES NOT CONSTITUTE AN ADMISSION THAT THE PUNCTURE GUARD WINGED SET CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. LIMITED INFORMATION HAS BEEN PROVIDED REGARDING THE ALLEGED PRODUCT PROBLEM AND OR WHETHER THE ALLEGED PRODUCT PROBLEM OCCURRED AS A RESULT OF USER ERROR AND/OR TECHNIQUE. IT IS ALSO NOTED THAT THE FACILITY, HAS NOT REPORTED AND/OR CONTACTED THE DEVICE MANUFACTURER REGARDING ANY TYPE OF PRODUCT PROBLEM OR MALFUNCTION INVOLVING AN ICU MEDICAL INC. DEVICE. THE EXACT CAUSE OF THE REPORTED INCIDENT CANNOT BE DETERMINED.