MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CANNULA,SOFTECH,ADULT W/7' STAR LUMEN; CANNULA, NASAL, OXYGEN

Model Number	IPN049742
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	03/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Mdr report key/report number (b)(4).
Event or Problem Description
Maude report: it was reported "silicone o2 tubing noted to have hardened and was switched out for new tubing.Wound rn's assessed patient and identified: left ear - top of ear, state iii, previous pressure injury; bottom/middle, new pressure injury due to o2 tubing, stage ii - offload and apply soothe and cool".Patient condition unknown at time of report.
Additional Manufacturer Narrative
Qn# (b)(4).Mdr report key/report number 11514842.Complaint verification testing could not be performed as it was reported that the sample is not available for return.The manufacturer (shengyurui medical) reports: "since the customer did not provide defective samples, no abnormality was found in the first retained sample of this batch of products after checking, and the products met the relevant registration requirements.The preliminary analysis is not in accordance with the principle of disposable use (results show that the plasticizer in the raw pvc after several times of alcohol disinfection can accelerate the migration.This product is disposable, do not recommend repeated use." 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.
Event or Problem Description
Maude report: it was reported "silicone o2 tubing noted to have hardened and was switched out for new tubing.Wound rn's assessed patient and identified: left ear - top of ear, state iii, previous pressure injury; bottom/middle, new pressure injury due to o2 tubing, stage ii - offload and apply soothe and cool".Patient condition unknown at time of report.

• Brand Name: HUDSON CANNULA,SOFTECH,ADULT W/7' STAR LUMEN
• Common Device Name: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11776823
• Report Number: 3011137372-2021-00134
• Device Sequence Number: 3137641
• Product Code: CAT
• UDI-Device Identifier: 14026704625366
• UDI-Public: 14026704625366
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: IPN049742
• Device Catalogue Number: 1820
• Device Lot Number: 200721
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention