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

Model Number	IPN046956
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the "comfort flo plus is breaking on the patient at the nares and corrugate tubing".No patient harm reported.Patient condition reported as "fine".
Event or Problem Description
It was reported the "comfort flo plus is breaking on the patient at the nares and corrugate tubing".No patient harm reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The actual sample involved in the reported complaint was not returned for evaluation; therefore, a sample of the same catalog number was taken from current production at the manufacturing facility.A visual exam was performed and no defects were observed.In the current manufacturing procedure 100% leak testing is conducted after assembly; therefore, any 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.

• Brand Name: HUDSON COMFORT FLO PLUS CANNULA W/CHIN STRAP-M
• Common Device Name: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11364713
• Report Number: 8040412-2021-00038
• Device Sequence Number: 13651263
• Product Code: CAT
• UDI-Device Identifier: 14026704343970
• UDI-Public: 14026704343970
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

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: IPN046956
• Device Catalogue Number: 2412-12
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1