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

Model Number IPN044066

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event 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".

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 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
• Type of Device: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11226946
• MDR Text Key: 239457993
• Report Number: 3011137372-2021-00003
• Device Sequence Number: 1
• Product Code: CAT
• UDI-Device Identifier: 04026704597451
• UDI-Public: 04026704597451
• 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: 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
• Device Operator: No Information
• 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 Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 05/10/2021
• Supplement Dates FDA Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1