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

Catalog Number 2411-03

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).

Event Description

Original customer complaint alleged the device became kinked when the infant moved its head resulting in respiratory distress.It was then reported there were two episodes with this same patient.The issue was resolved by replacing the device.No necessary medical intervention was reported.The patient has been discharged.See companion mdr mfr.Rpt#: 3011137372-2019-00082 for capture of inital reported event.

Event Description

Original customer complaint alleged the device became kinked when the infant moved its head resulting in respiratory distress.It was then reported there were two episodes with this same patient.(continued) the issue was resolved by replacing the device.No necessary medical intervention was reported.The patient has been discharged.See companion mdr mfr.Rpt#3011137372-2019-00082 for capture of initial reported event.

Manufacturer Narrative

Qn# (b)(4).The supplier (salter labs) reports "product in question was unavailable for return or analysis, nor were photos provided and we were unable to confirm the complaint or determine its root cause.As with any flexible tubing, kinking can occur.Salter labs minimizes the risk of kinking by implementing 3-channel safety tubing to prevent total airflow occlusions in the event of a kink.Internal testing of our three channel tubing has demonstrated that oxygen flow is reduced by less than 10% even when it is severely kinked in two places.Since kinking can occur (though has a low complaint per million complaint rate), we have investigated tubing manufacturing, handling, packaging and shipping procedures in the past and have implemented various improvements.Improvements to our manufacturing processes have proven to reduce the susceptibility of kinking when in use.However, since none of the lot number were provided it is difficult to approximate the manufacturing date of the cannulas and the improvements made." 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

Original customer complaint alleged the device became kinked when the infant moved its head resulting in respiratory distress.It was then reported there were two episodes with this same patient.(continued) the issue was resolved by replacing the device.No necessary medical intervention was reported.The patient has been discharged.See companion mdr mfr.Rpt#3011137372-2019-00082 for capture of inital reported event.

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: 8465096
• MDR Text Key: 140329678
• Report Number: 3011137372-2019-00102
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• 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: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
• Patient Outcome(s): Other
• Patient Age: 3 MO