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

Qn#(b)(4).The results of the investigation are incomplete 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).A device history record (dhr) review could not be performed as the lot number was unknown.The actual sample was not returned for evaluation; therefore, ten pieces of catalog number 2412-13 were selected from current production at the manufacturing facility to test the reported defect.The samples were all visually inspected and no issues were observed.In addition, leak testing was also performed on all ten samples, and no leaks were detected.Because no sample was returned, the complaint could not be confirmed.In the current manufacturing procedure, 100% leak testing is conducted at the assembly area; therefore, any defects would be detected prior to release.

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: 5823136
• MDR Text Key: 50473940
• Report Number: 8040412-2016-00166
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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