Catalog Number 1770 |
Device Problem
Disconnection (1171)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device involved has not been received by the manufacturer for evaluation at the time of this report.However material from the production line was verified and no issues were found that can lead this customer complaint.The device history record of batch number 74e1701281 that belongs to catalog number 1770 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.Customer complaint cannot be confirmed based only on the information provided.To perform a proper investigation and determine the source of the alleged defect reported it is necessary to evaluate the sample involved in this complaint.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 device detached from the flow meter.Alleged event reported occurred prior to use on a patient.No patient harm or delay in therapy was reported.
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Manufacturer Narrative
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Qn# (b)(4).One unit of catalog number 1770 (nebulizer, large volume, var concentration) was received for analysis.During the visual inspection it was observed that the nut was missing on the device.No other issues were found.The customer complaint could not be confirmed as the nut was missing on the sample received.It was not possible to assemble the sample into the flowmeter of the oxygen tank to perform functional testing.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.Teleflex will continue to monitor and trend this failure mode.
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Event Description
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Customer complaint alleges the device detached from the flow meter.Alleged event reported occurred prior to use on a patient.No patient harm or delay in therapy was reported.
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Search Alerts/Recalls
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