Model Number IPN041365 |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/31/2023 |
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 during use on a patient, "plastic wasn't removed from tube and catching on one and second plastic was not removed in the slightest way and blocking the air coming through".As a result, the filter was changed out for another.No patient harm or injury.The patient status is reported as "fine".
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Manufacturer Narrative
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(b)(4).The additional information received on 06oct2023 reported that there was no clear evidence of crystallization, and the patient side sampling port was blocked.The patient was breathing spontaneously, and the filter was connected to the lma, pointed upwards.The reported complaint was confirmed based upon the investigation of the returned sample.An actual sample was received with open package for evaluation.The sample was closely examined by visual inspection which revealed that the luer port of the product was occluded by the housing material.A device history record review was performed, and no relevant findings were identified.The root cause was determined as supplier related.Further actions and were initiated under teleflex quality systems to evaluate this issue.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that during use on a patient, "plastic wasn't removed from tube and catching on one and second plastic was not removed in the slightest way and blocking the air coming through".As a result, the filter was changed out for another.No patient harm or injury.The patient status is reported as "fine".
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Search Alerts/Recalls
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