Catalog Number 175040 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2023 |
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: (b)(6).2023, the surgery requires the insertion of a laryngeal mask, which is difficult to insert and causes air leakage during the process.Patient reported as good post the procedure.
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Manufacturer Narrative
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Qn#(b)(4) the sample was not returned to the manufacturer.The manufacturer reported: "no actual sample was received for further investigation.Based on the complaint description and review of dhr for the affected lot, there is no abnormalities was identified.There was also no nc raised during the production of the lot.As there was no complaint sample was returned to confirmed on the actual root cause, then the root cause for this complaint is concluded as 'undetermined/unknown'.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: (b)(6) 2023, the surgery requires the insertion of a laryngeal mask, which is difficult to insert and causes air leakage during the process.Patient reported as good post the procedure.
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Search Alerts/Recalls
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