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

Catalog Number 2412-13

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2016

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 there are small holes near the nare connection that leaks oxygen.The device was removed and a new device obtained.No patient injury/harm reported.

Manufacturer Narrative

(b)(4).Corrected data: (b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there were an array of holes in the tubing.The failure could be replicated by pulling and/or twisting sections of the tube that previously were acceptable.A section of the tubing was sent to the vendor of the component ((b)(4)) , and they confirmed that stress due to pulling and/or twisting likely caused the failure.In addition, the manufacturing facility performs 100% leak testing during the assembly process and a 100% visual inspection at the packing area; thus, any defects would be detected prior to release.It is recommended that the lanyard provided with the product be utilized around the neck to help mitigate potential stress on the tubing during use.If the tube is pulled or twisted with enough force the tubing can fail.

Event Description

The customer alleges that there are small holes near the nare connection that leaks oxygen.The device was removed and a new device obtained.No patient injury/harm reported.

• Brand Name: HUDSON COMFORT FLO PLUS CANNULA W/CHIN STRAP-S
• Type of Device: NASAL OXYGEN CANNULA
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia NC
• 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: 5823007
• MDR Text Key: 50468588
• Report Number: 8040412-2016-00162
• 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: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2412-13
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2016
• 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