MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MASK,MEDIUM CONC,ELONG,ADULT; MASK, OXYGEN

Catalog Number 1041

Device Problems Disconnection (1171); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient code chosen was based on the information provided in the report.A death was reported, however there was no report that the teleflex device involved caused or contributed.Per report the cause of death was pneumonia by the attending physician.Based on the event description, the nurse confirmed there was no problem with the device prior to the adverse event.The description of the tubing (torn and twisted 47cm from the mask) is not indicative of a manufacturing issue.Additional information was requested by teleflex.It was reported there was no additional information or photo available.A device history record review could not be conducted since the lot number was not provided.Other remarks: inspection of the device involved was not possible as the device sample or a photo was not provided.However, material from the production line was verified and no issues were found that can lead this customer complaint.Customer complaint cannot be confirmed based only on the information provided.To perform a proper and through investigation and determine a root cause, it is necessary to evaluate the sample involved.Root cause is undetermined.If the device becomes available at a later date, this report will be updated with the evaluation results.

Event Description

Complaint reads: "it was reported that (b)(6) 2018, am 8:06 nurse confirmed the tubing was no problem and there was consciousness of the patient.After a few minutes, a patient condition changed suddenly." (cont.) (cont.)" and user confirmed the torn off tube.After 30 mins resuscitation was performed, however death of a patient was confirmed (am 8:55).It was not the user complaint, we received this report from the officer of (b)(6) police, mr.(b)(6).Police is searching this issue now.Below information is from the police.It seemed that too much painful, a patient was torn off the tubing of the mask by oneself.The tubing was disconnected (torn and twisted) 47 cm from the mask side.The cause of the death was pneumonia by attending physician.Police would like to know the strength of the tube.".

• Brand Name: HUDSON MASK,MEDIUM CONC,ELONG,ADULT
• Type of Device: MASK, OXYGEN
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 8217745
• MDR Text Key: 132091689
• Report Number: 3004365956-2019-00007
• Device Sequence Number: 1
• Product Code: BYG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 1041
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.
• Patient Outcome(s): Other