TELEFLEX MEDICAL LMA FLEXIBLE PRECURVED CPV SIZE 4; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOG
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Catalog Number 1B2040 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/21/2020 |
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 "on both occasions, at the end of the procedures the tubing on each cuff pilot disconnected resulting in losing seal, at the end no impact or danger to the patient".No patient harm reported.The patient condition is reported as fine.
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Event Description
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It was reported "on both occasions, at the end of the procedures the tubing on each cuff pilot disconnected resulting in losing seal, at the end no impact or danger to the patient".No patient harm reported.The patient condition is reported as fine.
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Manufacturer Narrative
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Qn#(b)(4).Only the cuff pilot valve (cpv) and part of the inflation line was returned for evaluation.The partial returned sample was send to the manufacturing site for investigation.The manufacturing site reports: "the sample was tested and the joint between cpv and inflation line is still within specification".It was also reported that "there was a clean cut on the inflation line".The dhr was reviewed and no abnormalities were found.Based on the sample received, the complaint is confirmed.The cpv was within specification; however, the cut on the inflation line is slanted; indicating it had been cut with a sharp object.The complaint root cause is a non-manufacturing related or supplier related but the most probable root cause is unintentional user error.
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