Catalog Number 031-33J |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device involved has not been received by the manufacturer for evaluation at the time of this report.A device history record review could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed.Root cause cannot be determined.No corrective action can be established at this time.If the sample becomes available this report will be updated with the evaluation results.
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Event Description
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Customer complaint alleges "the user connected the adaptor to the flowmeter but air leakage occurred during setup because the connecting part of flow meter and adaptor was unstable." no patient involvement was reported.
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Event Description
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Customer complaint alleges "the user connected the adaptor to the flowmeter but air leakage occurred during setup because the connecting part of flow meter and adaptor was unstable." no patient involvement was reported.
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Manufacturer Narrative
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Qn#(b)(4).One unit of catalog number 031-33j (nebulizer adaptor 033, sterile, japanese) was received for analysis.During the visual inspection it was observed that the nut was missing.No other issues were found.It was not possible to perform functional testing because the nut is missing; therefore, it could not be connected on the flowmeter of the oxygen tank.The complaint could not be confirmed since during the visual inspection it was observed that the nut was missing on this returned product.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specification.Teleflex will continue to track and trend this failure mode.
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Search Alerts/Recalls
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