As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 09/2020).
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It was reported that during a port placement procedure the 10cc syringe stopper allegedly fractured while attempting to access the right subclavian vein under negative pressure.Allegedly, air entered into the patients chest wall, and a postoperative x-ray of the upper right chest allegedly demonstrated a right pneumothorax.It was further reported that a chest tube was placed to treat the right pneumothorax.The current patient status is unknown.
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