The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
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The customer reported the medication propofol dripped out of the luer lock syringe, when the anesthesiologist went to put the syringe on the iv tubing.The incident was occurred when ready to inject into the patient.The plunger was not staying in place once deployed to deliver medication, resulting in the medication to come out the back end of the syringe.There was a chemical exposure in the patient's eye.The patient was reported to be asymptomatic, when asked in the recovery area by the anesthesiologist involved in the case.The anesthesiologist irrigated the effected eye with copious amounts of normal saline in additional to eye.The patient was believed to be discharged from the post-anesthesia care unit (pacu) area without any reported symptoms or complications with the eyes.
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