Catalog Number 192030 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/22/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device sample was not returned for evaluation at the time of this report.
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Event Description
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The event is reported as: the customer alleges the cuff is leaking prior to use.There was no patient involvement reported.
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Manufacturer Narrative
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(b)(4).Device history record (dhr) review was performed and there were no issues found that could have contributed to the reported failure.All processes were executed according to the standard operating methods.The sample was received used and in the original teleflex lma packaging with the pouch seal open.When the device was initially observed the distal end of the cuff appeared normal until pressure was put on the cuff.The cuff was deflated and left for 2 seconds.Then the cuff inflated back to the normal shape.The device was immersed into a beaker of water and checked for leakage.A bubble occurred inside the airway tube.A leak was observed from the tear at the distal end of the cuff.The reported defect was confirmed through functional and visual inspection.The possible root cause is suspected to be due to the use of tweezers during the touch up process, while removing glue from the inside of the distal end of the device after the assembly process.The operation work instruction for the gluing method has been revised.
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Event Description
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The customer alleges the cuff is leaking prior to use.There was no patient involvement reported.
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Search Alerts/Recalls
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