Catalog Number CS-25703-E |
Device Problem
Insufficient Information (3190)
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Patient Problem
Pneumothorax (2012)
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Event Date 03/23/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Physician reported the patient died unrelated to the device or pneumothorax.The customer was unwilling to provide the patient's date of death, cause of death, or relevant medical history.
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Event Description
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It was reported "the introducer needle was not hard enough to insert subclavian vein".The needle bent towards the lungs and caused a pneumothorax.It was reported the device was replaced.It was unknown if any treatment was provided for the pneumothorax.Additional information was received that the patient had died.The physician reported the pneumothorax was not the cause of death.The patient was well treated for, but other conditions have caused the death.It was reported the pneumothorax had resolved prior to the patient's death.
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Manufacturer Narrative
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Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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It was reported "the introducer needle was not hard enough to insert subclavian vein".The needle bent towards the lungs and caused a pneumothorax.It was reported the device was replaced.It was unknown if any treatment was provided for the pneumothorax.Additional information was received that the patient had died.The physician reported the pneumothorax was not the cause of death.The patient was well treated for, but other conditions have caused the death.It was reported the pneumothorax had resolved prior to the patient's death.
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Search Alerts/Recalls
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