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

Model Number IPN046956

Device Problem Material Separation (1562)

Patient Problem Low Oxygen Saturation (2477)

Event Date 03/07/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event 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".

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 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
• Type of Device: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11599630
• MDR Text Key: 243402186
• Report Number: 8040412-2021-00088
• Device Sequence Number: 1
• Product Code: CAT
• UDI-Device Identifier: 14026704343970
• UDI-Public: 14026704343970
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN046956
• Device Catalogue Number: 2412-12
• Device Lot Number: KMZ20M0255
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention