BAXTER HEALTHCARE CORPORATION CLEARLINK LUER ACTIVATED VALVE; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 2N8378 |
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 03/12/2020 |
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 that a clearlink system non-dehp catheter extension set that was attached to a patient's iv malfunctioned; further described as during computed tomography angiography the j loop split and resulted in a leak of contrast.Prior to the procedure, labs were taken and a j loop was attached and the set flushed well.There was no 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: correction: the device was received inside a plastic biohazard bag for evaluation.The used sample had an unknown white solution in the fluid path and was contaminated with blood.A visual inspection was performed which observed a burst near the two piece luer lock assembly.Due to the nature of the returned sample, no additional tests were performed. the reported condition was verified.The cause of the condition could not be determined; however the probable cause was end user related.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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