Catalog Number 391350 |
Device Problem
Difficult to Remove (1528)
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Patient Problem
Perforation of Vessels (2135)
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Event Date 10/31/2018 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that during use of the bd neoflon¿ iv cannula peels back after piercing venous blood vessels, making it difficult to remove the needle and the placement of the peripheral infusion fails.The peripheral blood vessels were damaged to such an extent that a deep line had to be placed.Cardiorespiratory causes stress for destabilization, resulting in (temporary) need for more respiratory support or cardiac stimulation.
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Manufacturer Narrative
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There is no sample and no photo returned for investigation of this complaint.Complaint will be reopened if sample is returned.A review of the device history record revealed no irregularities during the manufacture of the reported lot #.Based on the investigation of similar complaint, the probable root cause could be due to the tubing material.(b)(4) was issued to review the tubing material.
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Event Description
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It was reported that during use of the bd neoflon iv cannula peels back after piercing venous blood vessels, making it difficult to remove the needle and the placement of the peripheral infusion fails.The peripheral blood vessels were damaged to such an extent that a deep line had to be placed.Cardiorespiratory causes stress for destabilization, resulting in (temporary) need for more respiratory support or cardiac stimulation.
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Search Alerts/Recalls
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