COOK INC UNKNOWN; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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Model Number N/A |
Device Problems
Unraveled Material (1664); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown or unavailable.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 unraveled.During the placement procedure, the wire guide entered the vessel; however, it could not be advanced and became stuck in the needle.The wire guide was then removed, and unraveling was discovered.Another kit was required to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
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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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