The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 27oct2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).
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It was reported that a "physician performed a coolief lumbar procedure.After completing the procedure and the needles removed, the physician noticed the orange plastic sheath covering the needle was peeled back.The physician had trouble inserting the needle initially but finally got it through the skin.Also, the physician noticed very high impedance levels burning with this defective needle.The patient was not harmed." no additional information was provided.
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