Model Number N/A |
Device Problems
Break (1069); Unraveled Material (1664); Difficult to Advance (2920)
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Patient Problem
Foreign Body In Patient (2687)
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Event Type
Injury
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Manufacturer Narrative
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This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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It was reported that the wire guide of an unknown cook central venous catheter separated.During the placement procedure, the wire guide entered the internal jugular (ij) vein; however, it could not be advanced and became stuck in the needle.The wire guide was then removed, and unraveling and separation were discovered.Pieces of the wire were retained in the ij.As result the patient required an additional procedure in the operating room to remove the wire guide fragments from the vessel.No other adverse effects were reported for this incident.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: d9, h3 this report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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Search Alerts/Recalls
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