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Catalog Number JC7751 |
Device Problems
Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/30/2020 |
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 a y-type blood/soln set leaked.¿after spiking product and releasing the roller clamp to run wide open,¿ fluid was observed on the tubing.Upon further inspection, a ¿tear was noted on the tubing at point where roller clamp had previously been engaged¿.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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Additional information was added to d10, h3, h4 and h6.Correction to d4: lot # and f10/h6: device codes (missing code for tear; add 4008).D4: lot # was either dr20e17025 or dr20a16067.H4: the suspected lot # dr20e17025 was manufactured on 05/18/2020.The suspected lot # dr20a16067 was manufactured on 01/17/2020.H10: the device was received for evaluation.Visual inspection was performed; all components were correctly placed and according to specifications.However, a hole on the tubing was identified which would result in a leak.The reported condition was verified.The cause of the hole could not be determined.A batch review was conducted for both lots and there were no deviations found related to this reported condition during the manufacture of these lots.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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