Model Number N/A |
Device Problem
Material Separation (1562)
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Patient Problems
Surgical procedure, additional (2564); No Code Available (3191)
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Event Date 04/20/2015 |
Event Type
Injury
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Event Description
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The left radial arterial line was inserted into a 67 year old female patient on (b)(6) 2015 at 14:00.On (b)(6) 2015 the healing wound looked like it was impregnated with blood.When the bandage was removed the user facility could see that the catheter was broken.The patient required new arterial canalization.
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Manufacturer Narrative
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(b)(4).This event is currently under investigation.
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Manufacturer Narrative
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(b)(4).Event evaluation: a review of complaint history, quality control and a visual inspection of the returned used device was conducted during the investigation.The visual examination and viewing of the supplied video confirmed a tear in the shaft material, located at the base of the fitting.There is no evidence to suggest that the product was not manufactured to specifications.We are unable to determine the root cause of the failure mode experienced.Per the quality engineering risk assessment (qera) no further risk reduction is required.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.
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Event Description
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The left radial arterial line was inserted into a (b)(6) year old female patient on (b)(6) 2015 at 14:00.On (b)(6) 2015, the healing wound looked like it was impregnated with blood.When the bandage was removed, the user facility could see that the catheter was broken.The patient required new arterial canalization.
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Search Alerts/Recalls
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