MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CANNULA,SOFTECH,ADULT W/7' STAR LUMEN; CANNULA, NASAL, OXYGEN

Model Number	IPN049742
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "patient was on cannula 1820 for 2-3 weeks, maybe longer.Skin breakdown occurred".Unknown what type of skin breakdown occurred at time of report.No patient harm reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).The sample was returned and sent to the manufacturer (shengyurui medical) for investigation.Shengyurui medical reports: "patient was on cannula 1820 for 2-3 weeks, maybe longer.Skin breakdown occurred.So , the problem was caused by the customer's failure to comply with the "disposable" requirement.It is concluded that the plasticizer in raw material pvc may be migrated acceleratly if disinfected by alcohol many times.The product is disposable and is not recommended for repeated use.".
Event or Problem Description
It was reported "patient was on cannula 1820 for 2-3 weeks, maybe longer.Skin breakdown occurred." unknown what type of skin breakdown occurred at time of report.No patient harm reported.Patient condition reported as "fine.".

• Brand Name: HUDSON CANNULA,SOFTECH,ADULT W/7' STAR LUMEN
• Common Device Name: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11685754
• Report Number: 3011137372-2021-00106
• Device Sequence Number: 16868687
• Product Code: CAT
• UDI-Device Identifier: 14026704625366
• UDI-Public: 14026704625366
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

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: IPN049742
• Device Catalogue Number: 1820
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1