TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE; NEBULIZER (DIRECT PATIENT INTE
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Catalog Number 031-33J |
Device Problem
Connection Problem (2900)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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Event Description
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Customer complaint alleges that the user attempted to connect the nebulizer adaptor to the flowmeter, however, the screw was not tightened therefore, a new unit was used instead.No patient involvement was reported.
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Manufacturer Narrative
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Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Oxygen entrainment testing was performed and during the setup it was observed that the assembly of the nut adaptor and the upper body was unstable.Even with that condition, the sample was able to be tested on oxygen entrainment testing.After the testing was finished, the adaptor was carefully disassembled from the upper body and it was visually inspected.During the visual inspection wear was found on the internal tabs.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the complaint is confirmed.Although the complaint is confirmed, 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 was most likely caused by the end user during the connection of the adaptor into the flowmeter that causes an unstable connection issue.
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Event Description
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Customer complaint alleges that the user attempted to connect the nebulizer adaptor to the flowmeter, however, the screw was not tightened therefore, a new unit was used instead.No patient involvement was reported.
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Search Alerts/Recalls
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