Model Number N/A |
Device Problems
Crack (1135); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/17/2024 |
Event Type
Injury
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Manufacturer Narrative
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D1 - device name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set.E1 - customer (person): phone: (b)(6), additional phone: (b)(6), fax: (b)(6).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 leakage was found coming from the blue port of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter following femoral placement in a 75-year-old female patient.The patient did not experience any adverse effects due to this occurrence.A photo provided by the customer shows a crack in the catheter hub.Additional information regarding event details has been requested but is currently unavailable.
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Event Description
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In additional information it was reported that the leak was noted immediately after the procedure during injection.The patient required replacement of the cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Search Alerts/Recalls
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