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Catalog Number 031-33J |
Device Problem
Connection Problem (2900)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/15/2017 |
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 was not returned to the manufacturer at the time of this report.A picture of the alleged defect was not provided.The batch number provided for this complaint was not found to have ever been registered at with the teleflex (b)(4).Customer complaint cannot be confirmed, based only on the information received.In order to perform a proper investigation, it is necessary to have the device sample involved in the complaint.If the device sample becomes available this investigation will be updated with the evaluation results.
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Event Description
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Customer complaint alleges, "the user noticed that the connection part assembly to the flowmeter was unstably attached to the adaptor.Therefore, a new unit was used instead".The alleged defect was detected during use.No report of injury or harm to the patient.Patient condition reported as "fine".
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Manufacturer Narrative
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(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the sample had signs of use as damages were found on the internal locks of the adaptor.No other issues were found.The damage found on the internal locks of the adaptor is not acceptable according to current specifications.Functional testing was performed and no issues were found.However, during the setup of the oxygen entrainment testing, it was observed that the assembly of the nut adaptor component and the upper body component was unstable as the upper body was disconnected from the nut adaptor; therefore it was not possible to perform such testing.Attempts to duplicate the failure mode "flowmeter connection unstable" were performed and there are two ways to duplicate them: the first one is by overtightening the nut adaptor onto the flow meter.The second one is by manipulating the assembly connection until components get disconnected.Based on the investigation performed, the reported complaint was confirmed.Although the condition reported is observed on the sample provided, there is not sufficient evidence to assure that this issue was originated during the manufacturing assembly or molding process (damaged internal locks).(con't).Other remarks: the root cause for the condition reported could not be identified.However, personnel from adaptor assembly line at the manufacturing facility were notified on feb-27-2017 for awareness.A conclusion code could not be found as the complaint was confirmed; however, a root cause was not established.
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Event Description
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Customer complaint alleges, "the user noticed that the connection part assembly to the flowmeter was unstably attached to the adaptor.Therefore, a new unit was used instead".The alleged defect was detected during use.No report of injury or harm to the patient.Patient condition reported as "fine".
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Search Alerts/Recalls
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