Model Number N/A |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/06/2024 |
Event Type
malfunction
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Event Description
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It was reported that the catheter lumen with a blue port of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set was noted to be occluded immediately after placement.The catheter was replaced during the same procedure.As reported, there were no adverse effects or additional procedures for the patient due to this occurrence.Additional information regarding the event has been requested but is currently unavailable.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown or unavailable.D1: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set.E1- customer (person): (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 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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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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Manufacturer Narrative
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Device evaluated by mfg.= other (81) - device evaluation has begun; however, a conclusion is not yet available.Device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.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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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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Event Description
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It was reported in additional information that the lumens were filled with either saline solution or heparinized saline solution prior to catheter introduction.All the lumens were able to be flushed successfully prior to placement.All unused lumens were maintained with either continuous saline, heparinized saline drip, or locked with heparinized saline solution.
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Search Alerts/Recalls
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