Catalog Number 689239 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/31/2022 |
Event Type
malfunction
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Event Description
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The account alleges that during a hemodynamic pressure monitoring procedure, leakage occurred from a crack in the 3-way stopcock at the elbow of the syringe.No patient injury to report.
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Manufacturer Narrative
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The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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Manufacturer Narrative
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The suspect device was returned for evaluation.The device was examined visually, and functional testing was performed.The complaint was confirmed.The root cause is attributed to the significant force being applied to the device.A review of the device history record was performed, and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number were found.
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Manufacturer Narrative
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The suspect device was returned for investigation.The device was examined visually and microscopically.The complaint is confirmed.The root cause is attributed to over-tightening the device.[use error].The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number have been identified.
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Search Alerts/Recalls
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