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

Catalog Number 2411-03

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has not been returned to the manufacturer at the time of this report.The investigation into this complaint in still in progress.

Event Description

Customer complaint alleges the cannula came apart while on the patient.Alleged issue reported as during use.It was reported there was no injury or consequence to the patient.

Manufacturer Narrative

(b)(4).The sample was returned by the customer and forwarded to salter labs for evaluation.The investigation received by salter labs is as follows: "evidence of mek bonding material was found.Additionally a dhr review was conducted regarding the p/n and lot number identified in the complaints.No issues or finding were reported and the product met all applicable testing requirements.While we were not able to determine a specific cause for the bond failure, please be advised that salter has long used several in-process manufacturing controls to assure the quality and strength of our cannula bonds.This includes, but is not limited to, extensive operator training, custom fixtures to control solvent dipping length, and routine sample testing of bond strengths throughout each shift, utilizing both non-destructive and destructive test methods.Additionally, salter labs monitors complaints for issue or event trends.While this complaint has been entered into our complaint database and trending software, a trend for bond disconnections based on the number of units sold has not yet been identified.Salter labs will continue to be monitored complaint trends." other remarks: a conclusion code was not found as the complaint was confirmed; however, a root cause could not be identified.

Event Description

Customer complaint alleges the cannula came apart while on the patient.Alleged issue reported as during use.It was reported there was no injury or consequence to the patient.

• Brand Name: HUDSON INFANT COMFORT FLO NASAL CANNULA
• Type of Device: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6618098
• MDR Text Key: 76848048
• Report Number: 3011137372-2017-00196
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2411-03
• Device Lot Number: 102615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1