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U.S. Department of Health and Human Services

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

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TELEFLEX MEDICAL HUDSON ET TUBE,CF,7.5 TUBE, TRACHEAL (W/WO CONNECTOR Back to Search Results
Catalog Number V5-10115
Device Problem Detachment of Device or device Component
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.

 
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Brand NameHUDSON ET TUBE,CF,7.5
Type of DeviceTUBE, 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 Key8483998
Report Number3003898360-2019-00375
Device Sequence Number1
Product CodeBTR
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 Received04/04/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberV5-10115
Device LOT Number73J1800119
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/06/2018
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
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