MAUDE Adverse Event Report: TELEFLEX MEDICAL MASK,TRACHEOSTOMY,PEDIATRIC; MASK, OXYGEN

Catalog Number 1076

Device Problem Material Integrity Problem (2978)

Patient Problem Tissue Breakdown (2681)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

Customer reported skin breakdown on three separate individuals during use of device.It was reported the patient had skin breakdown from friction of the trach mask and nursing addressed the skin.

• Brand Name: MASK,TRACHEOSTOMY,PEDIATRIC
• Type of Device: MASK, OXYGEN
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10264602
• MDR Text Key: 198537730
• Report Number: 3004365956-2020-00138
• Device Sequence Number: 1
• Product Code: BYG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1076
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.