MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON SOFTECH PLUS ADULT CANNULA,7' GRN STAR-; CANNULA, NASAL, OXYGEN

Model Number	IPN049730
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	09/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.Manufacturer checked the first retained sample from the same batch, 200725-1 and found no abnormality.A device history record review was not conducted.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 that:" hudson rci adult softech plus nasal cannula.These don't seem to be fitting the patients well.They won't stay in place despite which way they are placed.This then becomes uncomfortable for the patient and reduces the therapeutic significance".No patient harm or injury reported.Device was exchanged for an oxygen mask.Patient condition reported as "fine".

• Brand Name: HUDSON SOFTECH PLUS ADULT CANNULA,7' GRN STAR-
• Common Device Name: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12531150
• Report Number: 3011137372-2021-00252
• Device Sequence Number: 1361719
• Product Code: CAT
• UDI-Device Identifier: 14026704625243
• UDI-Public: 14026704625243
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/02/2021

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: No Information
• Device Model Number: IPN049730
• Device Catalogue Number: 1870
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1