Catalog Number 037-09 |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/07/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.A device history review could not be performed; no lot number was supplied by the customer.No sample available from the customer to investigate.Root cause is unknown.Teleflex will continue to monitor feedback from the customers on issues related to insufficient aerosol on water bottle products.
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Event Description
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The customer alleges that the unit does not produce sufficient aerosol.This issue is causing a drying of the trach/et tube.
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Manufacturer Narrative
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(b)(4).A device history record (dhr) review was performed on the lot number of the bottle returned by the customer (127150).There were no issues found that may have contributed to any quality issues reported.All process parameters were within specification and all in-process qa inspections were acceptable.One unit of product code 037-09 (aquapak , 760 ml) was received for analysis.The sample includes a unit of subassembly (b)(4) (028 neb adaptor phantom holder) and one empty sterile water aquapak bottle.During the visual inspection it was observed that the sample was not received in the original package and had signs of use.It was also noticed that the puncture pin protector was missing.Functional testing was performed and there were no issues found.As additional test, oxygen entrainment testing was performed.The aquapak bottle was filled with sterile water and was assembled and tested with subassembly (b)(4).During the testing no issues or discrepancies were found that could lead to the condition reported by the customer.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.
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Event Description
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The customer alleges that the unit does not produce sufficient aerosol.This issue is causing a drying of the trach/et tube.
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Search Alerts/Recalls
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