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

Model Number	IPN044067
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	06/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Mdr report key/report number: (b)(4).
Event or Problem Description
Complaint from maude database: narrative from staff: infant's nasal cannula prongs found during morning routine hands on care with one side of the tubing disconnected/broken at hub.Infant not receiving full amount of air flow as ordered.Unknown when disconnection happened.Manufacturer response for hudson rci comfort flo nasal cannula.Premature., comfort flo nasal cannula (per site reporter): manufacturer representative is working on gathering information and device will be provided to him once a shipper kit is sent to us.
Additional Manufacturer Narrative
Qn#(b)(4).Mdr report key/report number: (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.
Event or Problem Description
Complaint from maude database: narrative from staff: infant's nasal cannula prongs found during morning routine hands on care with one side of the tubing disconnected/broken at hub.Infant not receiving full amount of air flow as ordered.Unknown when disconnection happened.Manufacturer response for hudson rci comfort flo nasal cannula.Premature., comfort flo nasal cannula (per site reporter): manufacturer representative is working on gathering information and device will be provided to him once a shipper kit is sent to us.

• Brand Name: HUDSON PREMATURE COMFORT FLO NASAL CANNULA
• Common Device Name: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12315441
• Report Number: 8040412-2021-00211
• Device Sequence Number: 4672159
• Product Code: CAT
• UDI-Device Identifier: 04026704597468
• UDI-Public: 04026704597468
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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: IPN044067
• Device Catalogue Number: 2411-04
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 10/13/2021
• 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