Catalog Number 2C8931 |
Device Problems
Disconnection (1171); Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/03/2023 |
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 both sides of the manifold of a clearlink system continu-flo solution set was loosely connected.This issue was further described as, ¿the connections were hand tightened twice prior to the tubing becoming disconnected¿.It was not specified when in the process step this occurred.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: update to an unspecified quantity (previously reported as one).The loose connections were noted upon removing the tubing from the package.H10: the actual device was not available; however, one (1) companion sample was received for evaluation.A visual inspection was performed with the naked eye which did not identify any abnormalities that could have contributed to the reported condition; all components were correctly placed and according to the specification.The sample was submitted to pressure testing and no leak was noted in the set.Pull test was also performed and no separation was observed.The reported condition could not be verified on the companion sample.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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