MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON INFANT COMFORT FLO NASAL CANNULA; CANNULA, NASAL, OXYGEN

Model Number	IPN044066
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the "2411-03 infant high flow cannula was found to be pulling apart near the prongs".No medical intervention required.No patient injury or desaturation reported.User replaced device with a new device.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The sample was sent to the manufacturer (sunmed) for investigation.The manufacturer reports: "the returned unit's facepiece was found to have a separation occurring at the seam.There are multiple variables, both through the manufacturing process, as well as in the end user environment that could contribute to this failure mode.A look at the batch records confirms that this appears to be an isolated incident with lot 012020 and furthermore, the tubing thickness was measured and found to be within specification." based on the investigation performed, the complaint was confirmed; however, a root cause could not be established.
Event or Problem Description
It was reported that the "2411-03 infant high flow cannula was found to be pulling apart near the prongs".No medical intervention required.No patient injury or desaturation reported.User replaced device with a new device.Patient condition reported as "fine".

• Brand Name: HUDSON INFANT COMFORT FLO NASAL CANNULA
• Common Device Name: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11226946
• Report Number: 3011137372-2021-00003
• Device Sequence Number: 3286002
• Product Code: CAT
• UDI-Device Identifier: 04026704597451
• UDI-Public: 04026704597451
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 01/04/2021

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 Expiration Date: 01/20/2025
• Device Model Number: IPN044066
• Device Catalogue Number: 2411-03
• Device Lot Number: 012020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1