MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ET TUBE,CF,7.5; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	V5-10115
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Death (1802)
Date of Event	03/13/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
(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.
Event or Problem Description
Customer complaint reported: "the et tube connector continuously became dislodged and the patient began to desaturate".It was reported the patient had a do not resuscitate order and therefore was not re-intubated.It was reported the patient expired (b)(6) 2019.

• Brand Name: HUDSON ET TUBE,CF,7.5
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8483998
• Report Number: 3003898360-2019-00375
• Device Sequence Number: 18633359
• Product Code: BTR
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 09/05/2023
• Device Catalogue Number: V5-10115
• Device Lot Number: 73J1800119
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED
• Outcome Attributed to Adverse Event: Death