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Catalog Number 17732 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/08/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device involved in this complaint has not been received by the manufacturer for evaluation at the time of this initial report.
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Event Description
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Customer complaint alleges, "in the middle of my uneventful nasal septoplasty case, there was a sudden loss of ability to adequately ventilate the patient.There was no harm to the patient.However, after a rapid search for the cause, it turned out there was a clean "laceration" across the plastic between the hard plastic end connecting to the endotracheal tube and the beginning of the softer plastic ridges".
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Manufacturer Narrative
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(b)(4).The sample was not returned for evaluation; however, the customer did provide a picture.Based on the review of the photo, the product tubing was torn.This may happen during mishandling of the product during use.At the manufacturing site, a 100% inspection and leak testing is performed; therefore, any defects would be detected prior to release.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 alleges, "in the middle of my uneventful nasal septoplasty case, there was a sudden loss of ability to adequately ventilate the patient.There was no harm to the patient.However, after a rapid search for the cause, it turned out there was a clean "laceration" across the plastic between the hard plastic end connecting to the endotracheal tube and the beginning of the softer plastic ridges".
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Search Alerts/Recalls
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