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

Catalog Number 2411-03

Device Problems Obstruction of Flow (2423); Material Deformation (2976)

Patient Problem Respiratory Distress (2045)

Event Date 01/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Teleflex has reached out to the customer for additional information regarding any necessary medical intervention and patient condition.No response received to date.The investigation of this complaint is still in progress.

Event Description

Customer complaint received via medwatch alleges "nursing and respiratory therapy staff have reported the nasal cannula is kinking n ear the connection junction and impeding air flow, resulting in respiratory distress.This has been observed to occur with the baby's head movement and not with repositioning the baby".Medwatch complaint form from the user facility is marked in report as "other serious (important medical event").No further details were reported.There was no report of necessary medical intervention or current patient condition.

Manufacturer Narrative

Qn#(b)(4).Additional information received and the customer: - "infant was born at 28w1d (prematurity) with chronic lung dz and phtn." - "rt replaced the cannula with a different product which resolved the issue.- "patient has been discharged." the supplier (salter labs) reports that a review of the part number found that this cannula is manufactured with 3-channel safety tubing to prevent total airflow occlusions in the event of a kink.It is important to note that internal testing for kinks on this type of product revealed only a 3% reduction of flow at 3 lpm and even less detectable reduction of flow at lower flow rates.Complaint verification testing could not be performed as no sample was returned for analysis.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 Description

Customer complaint received via medwatch alleges "nursing and respiratory therapy staff have reported the nasal cannula is kinking n ear the connection junction and impeding air flow, resulting in respiratory distress.(continued) this has been observed to occur with the baby's head movement and not with repositioning the baby".Medwatch complaint form from the user facility is marked in outcomes attributed to adverse event.As "other serious (important medical event".No further details were reported.There was no report of necessary medical intervention or current patient condition.

Event Description

Customer complaint received via medwatch alleges "nursing and respiratory therapy staff have reported the nasal cannula is kinking n ear the connection junction and impeding air flow, resulting in respiratory distress.(continued) this has been observed to occur with the baby's head movement and not with repositioning the baby".Medwatch complaint form from the user facility is marked in section b.2.As "other serious (important medical event".No further details were reported.There was no report of necessary medical intervention or current patient condition.

Manufacturer Narrative

(b)(4).Corrected data: section b.1 - 'adverse event' added section b.2 - 'other serious event' added section h.1 - corrected to 'serious injury'.

• Brand Name: HUDSON INFANT COMFORT FLO NASAL CANNULA
• Type of Device: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8446677
• MDR Text Key: 139698882
• Report Number: 3011137372-2019-00082
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2411-03
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2019
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
• Patient Outcome(s): Other
• Patient Age: 3 MO