TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE; NEBULIZER (DIRECT PATIENT INTE
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Catalog Number 031-33J |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the alleged defect was not provided at the time of this report.The device history record (dhr) of the device has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.Dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based on the information received.It is necessary to have the physical sample in order to perform a proper investigation to confirm the alleged defect, determine a root cause and establish corrective actions.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 connecting part of flow meter and adaptor was unstable, then it was replaced by a new kit." report states there was not patient involvement.
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Manufacturer Narrative
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(b)(4).The sample was returned for evaluation.The sample was returned for evaluation.A visual exam was performed and it was observed that the connection of the adaptor to the upper body was loose.It was also noticed that there was wear on the internal threads of the adaptor.Functional testing was also performed and the sample passed the tests.During the setup of the oxygen entrainment testing, however, it was observed that the assembly of the nut adaptor and the upper body component was unstable.Even with that condition, the sample was able to be tested; however, the testing failed.The sample was then assembled with a sterile water concha mini bottle.The sample failed the oxygen entrainment testing again.Attempts to duplicate the failure mode were performed and there are two ways to duplicate them: the first one is by overtightening the nut adaptor into the flow meter.The second one is by manipulating the assembly connection.Based on the investigation performed, the reported complaint was confirmed.Although the condition observed on the sample provided, there is not sufficient evidence to assure that this issue was originated during the manufacturing assembly or molding process.The wear on the internal tabs of the adaptor most likely was caused by the end user during the connection of the adaptor into the flowmeter.However, the personnel of the assembly line were notified on (b)(6) 2018 for awareness.
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Event Description
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Customer complaint alleges "the connecting part of flow meter and adaptor was unstable, then it was replaced by a new kit." report states there was not patient involvement.
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Search Alerts/Recalls
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