Catalog Number FNC1172 |
Device Problems
Fluid/Blood Leak (1250); Material Perforation (2205)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/10/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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 the drip chamber a of clearlink y-type blood set was perforated which resulted in a leak.This issue was identified during infusion of sodium chloride 0.9% while doing a procedure to a patient in the intensive care unit (icu).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 b5: additional information was received stating the issue was identified ¿before¿ the patient infusion (previously reported as ¿during infusion¿).H10: the actual device was not available; however, a video of the sample was provided for evaluation.Visual inspection was performed using the naked eye which observed a leakage from the hand pump.The reported condition was verified.The cause of the condition was due to a manufacturing related issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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