Model Number IPN037640 |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 12/01/2021 |
Event Type
malfunction
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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: "in (b)(6) 2021, in different departments of the hospital, users reported issues when using arterial catheters.There was an occlusion of the catheters leading to sample difficulties, flushing numerous times and difficulties reading the blood pressure date." it was reported the issue led to early replacement of the device with increased risk of infection.It was reported some patients had thrombosis, but no other details could be provided.There were no clinical consequences for patients and it was reported "they are all fine".
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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.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.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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It was reported that: "in december 2021, in different departments of the hospital, users reported issues when using arterial catheters.There was an occlusion of the catheters leading to sample difficulties, flushing numerous times and difficulties reading the blood pressure date." it was reported the issue led to early replacement of the device with increased risk of infection.It was reported some patients had thrombosis, but no other details could be provided.There were no clinical consequences for patients and it was reported "they are all fine".
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Search Alerts/Recalls
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