MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON COMFORT FLO PLUS CANNULA W/CHIN STRAP-M; CANNULA, NASAL, OXYGEN

Catalog Number 2412-12

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The complaint is reported as: "comfort flo plus cannula separated at the junction of the cannula and tubing.".No patient injury reported.Patient condition listed as "fine".

Event Description

The complaint is reported as: "comfort flo plus cannula seperated at the junction of the cannula and tubing." no patient injury reported.Patient condition listed as "fine".

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the strap was disconnected and the tubing was stretched.Based on the visual exam the complaint was confirmed.The defect was detected during use on a patient.The disconnection may occur due to mishandling of the product during usage.The tubing was stretched which may be due to extra force applied to the device during usage and cause it to detach.In the current manufacturing procedure 100% leak testing and visual inspection is conducted after the assembly process.Any defects would be detected prior to release from the manufacturing facility.

• Brand Name: HUDSON COMFORT FLO PLUS CANNULA W/CHIN STRAP-M
• Type of Device: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• MDR Report Key: 8655512
• MDR Text Key: 147338607
• Report Number: 8040412-2019-00120
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2412-12
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Date Manufacturer Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1