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

Catalog Number 2412-11

Device Problems Leak/Splash (1354); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

Event Description

The customer alleges that the tubing of the cannula appears to have stretched/fractured.The cannula tubing leaks.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The sample was returned for evaluation.A visual exam was performed and it was observed that there was a hole in the tube.The tubing of the cannula appears to have disintegrated/stretched and fractured, and the cannula tubing leaks badly.It is possible that this defect occurred due to mishandling the product.The failure was reported during use.The instructions for use (ifu) mentions that the tubing should not be stretched to remove condensation, or damage/malfunction may occur.In the current manufacturing procedure, 100% leak testing is conducted during the assembly process and 100% visual inspection is done at the packing area.Any defective products would be detected prior to release from the manufacturing facility.

Event Description

The customer alleges that the tubing of the cannula appears to have stretched/fractured.The cannula tubing leaks.The patient's condition is reported as fine.

• Brand Name: HUDSON COMFORT FLO PLUS CANNULA W/CHIN STRAP-L
• Type of Device: NASAL OXYGEN CANNULA
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL; po box 28, kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6099852
• MDR Text Key: 59783929
• Report Number: 8040412-2016-00257
• 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: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2412-11
• Device Lot Number: 201626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1