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Catalog Number 7N8399 |
Device Problems
Backflow (1064); Crack (1135); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 backflow was observed in a one-link needle-free iv connector.While connected to a pediatric patient, there was blood reflux noted in the tubing "through the q-site" resulting in a possible external leak onto the "patient's bed".A crack was observed; however, it was not specified as to the location of the crack.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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H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; 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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