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

Catalog Number V5-10115

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Death (1802)

Event Date 03/13/2019

Event Type  Death  

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 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
• Type of Device: TUBE, TRACHEAL (W/WO CONNECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 8483998
• MDR Text Key: 140944976
• Report Number: 3003898360-2019-00375
• Device Sequence Number: 1
• Product Code: BTR
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K822082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,HEALTH

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/14/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 04/04/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: NO INFORMATION
• Device Catalogue Number: V5-10115
• Device LOT Number: 73J1800119
• Was Device Available For Evaluation?: Yes

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/14/2019
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 09/06/2018
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 04/04/2019 Patient Sequence Number: 1

Treatment

NONE REPORTED