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Catalog Number ASKU |
Device Problems
Crack (1135); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter address: (b)(6).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 an unspecified access set was leaking.During infusion, the y connection site to the tubing was leaking, and upon changing the tubing, it was discovered that the tubing tip was cracked.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: 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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