MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CANNULA,SOFTECH,ADULT W/7' STAR LUMEN; NASAL OXYGEN CANNULA

Catalog Number 1820

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2016

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 end of the device that connects to the oxygen flowmeter is slipping off when oxygen is being administered to a patient.The tubing will not stay on the patient.

Manufacturer Narrative

(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 not returned for evaluation; therefore, the complaint could not be confirmed.If the sample is returned, a follow-up report will be submitted with investigation results.

Event Description

The customer alleges that the end of the device that connects to the oxygen flowmeter is slipping off when oxygen is being administered to a patient.The tubing will not stay on the patient.

• Brand Name: HUDSON CANNULA,SOFTECH,ADULT W/7' STAR LUMEN
• Type of Device: NASAL OXYGEN CANNULA
• 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: 5650674
• MDR Text Key: 45653131
• Report Number: 3011137372-2016-00113
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1820
• Device Lot Number: 114208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2016
• 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