Catalog Number 7N8371 |
Device Problems
Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/04/2023 |
Event Type
malfunction
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Event Description
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It was reported that a one-link non-dehp y-type microbore catheter extension set leaked.Furthermore, during patient plasma infusion the connection was noted to be "very loose and the tubing leaked".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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Should additional relevant information become available, a supplemental report will be submitted.
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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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Manufacturer Narrative
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Correction/additional information to b5: it was further reported that an unspecified quantity [two (2) to three (3)] one-link non-dehp y-type microbore catheter extension sets had loose hubs; further described as "not tight out of the package like usual." h10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection was performed to the photograph using the naked eye which did not identify any abnormalities that could have contributed to the reported condition.The reported condition is not clearly observed via the provided photograph and due to the nature of the returned sample no additional testing could be performed.Therefore, the reported problem could not be verified or refuted.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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