Model Number 041210002A |
Device Problems
Fluid/Blood Leak (1250); Leak/Splash (1354); Air/Gas in Device (4062)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/01/2022 |
Event Type
Injury
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Event Description
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Our 4 way stopcock was connected to the patient and then to the contrast line.3 occasion where the stopcock would continuously leak from the center port and 1 occasion where it sucked in air through the line.
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Manufacturer Narrative
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According to the customer, the sample was not available for review.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, the results are inconclusive and determining a root cause and corrective action is not possible.
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Manufacturer Narrative
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A review of the dhr and inspection records was conducted, and no similar concerns were found.32 sealed samples were returned for review.There was no sample marked defective returned.Five random samples were leak tested using a water filled syringe and two out of the five leaked from underneath the core/handle.Therefore, this complaint was confirmed.A closer examination of the core/handle assembly confirmed the core/handle was not fully seated inside the stopcock body which would result in leakage.The most probable cause for the leakage was most likely related to the assembly of the core/handle with the stopcock body.The core/handle not being fully seated would result in the observed leakage.It could not be determined if the this issue was the result of a tolerance stack between the two components or if there was a machine malfunction that prevented the two components from seating properly.Engineering is aware of this issue and an investigation has been initiated to establish a definite root cause that will determine the corrective actions that need to be taken to prevent recurrence.
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Event Description
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Our 4 way stopcock was connected to the patient and then to the contrast line.3 occasion where the stopcock would continuously leak from the center port and 1 occasion where it sucked in air through the line.
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Search Alerts/Recalls
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