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 06/20/2018 |
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 received by the manufacturer at the time of this report.The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.All materials used during the assembly met current specifications.Dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed due the lack of device sample to perform a proper investigation to confirm the alleged defect, and determine the root cause.Root cause is unknown.No corrective actions can be assigned.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 had difficulty connecting the adaptor to the oxygen flow meter.Therefore, a new unit was used instead".No patient involvement was reported.
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Manufacturer Narrative
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(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.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 with no functional issues.After the testing was finished, the adaptor was carefully disassembled from the upper body and it was visually inspected.During the visual inspection it was found there was wear on the internal tabs.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.Personnel of the assembly line will be notified of this issue for awareness.
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Event Description
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Customer complaint alleges "the user had difficulty connecting the adaptor to the oxygen flow meter.Therefore, a new unit was used instead".No patient involvement was reported.
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Search Alerts/Recalls
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