Catalog Number ASKU |
Device Problems
Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/29/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The user facility submitted medwatch (b)(4) for this event.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that there were small holes in the tubing of an unspecified access set which resulted in backing up and fluid leak.The leak was observed during propofol infusion to the patient.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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Correction made to b5: it was reported that there were small holes in the tubing of an unspecified access set which resulted in blood backing up and blood leakage (previously submitted as fluid).H10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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