Catalog Number SAC-00820-PBX |
Device Problems
Unable to Obtain Readings (1516); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/04/2024 |
Event Type
malfunction
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Event Description
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It was reported that: the arterial catheter folded, which altered the patient internal pressure reading.There was no deterioration in his health.Associated complaints: 3006425876-2024-00306.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that: the arterial catheter folded, which altered the patient internal pressure reading.There was no deterioration in his health.Associated complaints: 3006425876-2024-00307 and 3006425876-2024-00306.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Search Alerts/Recalls
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