Catalog Number SAC-00818-PBX |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Obstruction of Flow (2423)
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Patient Problem
Discomfort (2330)
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Event Date 01/20/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Qn# (b)(4).
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Event Description
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Customer complaint is reported as: arterial catheters were dysfunctional.For several patients it was impossible to get a correct arterial pressure reading and sample was impossible.The consequence is a discomfort of the patients and a waste of time for medical staff.Then staff must quickly replace the device.No patient details were available at the time of this report.
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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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Event Description
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Customer complaint is reported as: arterial catheters were dysfunctional.For several patients it was impossible to get a correct arterial pressure reading and sample was impossible.The consequence is a discomfort of the patients and a waste of time for medical staff.Then staff must quickly replace the device.No patient details were available at the time of this report.
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Search Alerts/Recalls
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