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Catalog Number 105200-000030 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/04/2023 |
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 after the lma was inserted, the cuff would not inflate."the black scale in cuff pilot was still in the same position, so doctor changed to the new one bust still similar, doctor changed to the new lma again, it worked.Doctor tried to investigate by checking cuff pilot under the water, they found that there was some leakage between cuff pilot housing and tubing." no report of patient harm or injury.The patient status is reported as "fine".See associated mdr# 3009307931-2023-00005.
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Manufacturer Narrative
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Qn# (b)(4).Additional information received on 24 jan 2024 states that the deflation occured prior to use on the patient.No patient involvement.The sample was not returned to the manufacturer for evaluation.The manufacture reported: "there are no actual complaint samples returned to kulim site for investigation.Complaints photos and videos were provided for evaluation from the customer.A device history record review was performed, and no relevant findings were identified.Despite no complaint samples, it was confirmed that the cuff pilot valve was leaking based on the video provided from the customer.Therefore, the root cause is considered to be "manufacturing related".A non-conformance was opened by the manufacturing site to further evaluate this issue."teleflex will continue to monitor and trend on complaints 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 after the lma was inserted, the cuff would not inflate."the black scale in cuff pilot was still in the same position, so doctor changed to the new one bust still similar, doctor changed to the new lma again, it worked.Doctor tried to investigate by checking cuff pilot under the water, they found that there was some leakage between cuff pilot housing and tubing." no report of patient harm or injury.The patient status is reported as "fine".See associated mdr# 3009307931-2023-00005.
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Search Alerts/Recalls
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