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 12/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation report is incomplete at the time of this report.

Event Description

The customer alleges that the tubing disconnected during use.No patient injury/harm reported.

Manufacturer Narrative

(b)(4).Manufacturing records were reviewed and revealed that all relevant tests performed during the manufacturing process and final product release had met requirements.No nonconformity of this nature had been registered during the production of this lot.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 tubing disconnected during use.No patient injury/harm reported.

• 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; 2917 weck drive; research triangle park NC 27709
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5340384
• MDR Text Key: 34919482
• Report Number: 1044475-2016-00005
• 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: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• 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: 112407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/04/2016
• 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