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	Material Separation (1562)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	03/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "tubing separated from white connector at nasal prongs, while patient was wearing".It was reported patient desaturated to the low 80s.It was reported the defective cannula was replaced.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The actual device was not returned; however the customer provided a photo for evaluation.A visual exam was performed on the photo and it was observed that the tubing was detached.This may happen due to mishandling of the product during usage.It may also be due to extra force applied to the device during use.In the current manufacturing procedure, 100% leak testing and visual inspection is conducted after the assembly process; thus, defects would be detected prior to release from the manufacturing facility.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.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.,, if the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported "tubing separated from white connector at nasal prongs, while patient was wearing".It was reported patient desaturated to the low 80s.It was reported the defective cannula was replaced.Patient condition reported as "fine".

• 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: 11599630
• Report Number: 8040412-2021-00088
• Device Sequence Number: 3520256
• Product Code: CAT
• UDI-Device Identifier: 14026704343970
• UDI-Public: 14026704343970
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 03/08/2021

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: No Information
• Device Model Number: IPN046956
• Device Catalogue Number: 2412-12
• Device Lot Number: KMZ20M0255
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 04/23/2021
• 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