Catalog Number 031-33J |
Device Problems
Connection Problem (2900); Separation Problem (4043)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/07/2020 |
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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The complaint is reported as: "the connection part between the nut adaptor and the flowmeter was so unstable that it got detached during use.Therefore, a new unit was used instead.No harm to the patient occurred".The condition of the patient was reported as "fine".
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Event Description
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The complaint is reported as: "the connection part between the nut adaptor and the flowmeter was so unstable that it got detached during use.Therefore, a new unit was used instead.No harm to the patient occurred".The condition of the patient was reported as "fine".
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Manufacturer Narrative
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(b)(4).The customer complaint description states that the connection part between the nut adaptor and the flowmeter of product code 031-33j (nebulizer adaptor 033,sterile,japanese) was so unstable that it detached during use; however a different sample that is not part of product code 031-33j was received for evaluation.The complaint could not be confirmed as the actual sample was not returned.
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Search Alerts/Recalls
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