MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON COMFORT FLO PLUS CANNULA W/CHIN STRAP-L; CANNULA, NASAL, OXYGEN

Model Number	IPN046955
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).Mdr report key/report number (b)(4).
Event or Problem Description
Maude report: it was reported "the patient was on a high flow nansal cannula and upon assessment, the rn noted that the tubing that directly connects the piece under the patient's nose broke off from the nose attachment".No patient harm or injury reported.Patient condition not reported.
Additional Manufacturer Narrative
(b)(4).Mdr report key/report number 11391850 complaint verification testing could not be performed as it was reported that the sample is not available for return.In the current manufacturing procedure, 10o% leak testing and visual inspection is conducted after the assembly process; thus, defects would be detected prior to release from the manufacturing facility.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 "the patient was on a high flow nansal cannula and upon assessment, the rn noted that the tubing that directly connects the piece under the patient's nose broke off from the nose attachment".No patient harm or injury reported.Patient condition not reported.

• Brand Name: HUDSON COMFORT FLO PLUS CANNULA W/CHIN STRAP-L
• Common Device Name: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11794178
• Report Number: 8040412-2021-00141
• Device Sequence Number: 4043289
• Product Code: CAT
• UDI-Device Identifier: 14026704343963
• UDI-Public: 14026704343963
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN046955
• Device Catalogue Number: 2412-11
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1