MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CANNULA,OVER-THE-EAR W/FLARED NASAL PRO; CANNULA, NASAL, OXYGEN

Model Number	IPN913908
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A visual inspection of the product involved in the complaint was unable to be performed as the four pictures received by the customer, did not show a visual depiction of affected product code 1104 (hudson cannula).A device history record review could not be conducted since the lot number of the device was not provided.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
It was reported "direct patient contacted customer service regarding an allergic reaction from her nasal cannula".Unable to determine what type of allergic reaction patient had at time of report.Unknown patient condition at time of report although several attempts were made to patient for additional information.

• Brand Name: HUDSON CANNULA,OVER-THE-EAR W/FLARED NASAL PRO
• Common Device Name: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11935276
• Report Number: 3004365956-2021-00194
• Device Sequence Number: 3831963
• Product Code: CAT
• UDI-Device Identifier: 14026704656544
• UDI-Public: 14026704656544
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: IPN913908
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1