(b)(4).
Additional information received by teleflex: the patient had to be re-intubated 3 times due to the alleged connector issue reported.
Patient chart note by physician read "patient reintubated due to defective endotracheal tube adapter".
See mdr companion reports for capture of re-intubation reports for this patient mfr rpt#: 3003898360-2019-00384; 3003898360-2019-00385; 3003898360-2019-00386.
The device involved has not been received for evaluation by the manufacturer at the time of this report.
However, a variant model from the same family was used for the "verification of failure mode reported in the current manufacturing process".
Samples were taken from the current production and were visually inspected.
The issue reported was not observed in the current manufacturing process.
Other remarks: a device history record investigation did not show issues related to this complaint.
A record assessment (fmea) was conducted and no update is required.
The device sample is needed for a proper and thorough investigation.
Customer complaint cannot be confirmed based on the information received.
Root cause cannot be determined.
Corrective actions cannot be established.
If the device sample becomes available, this report will be updated with the evaluation results.
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