MAUDE Adverse Event Report: TELEFLEX HUDSON ETCO2 CANNULA, LARGE W/GAS SAMPLING LINE; CANNULA W/ GAS SAMPLING LINE

Catalog Number 1845

Device Problems Leak/Splash (1354); Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the etco2 sampling cannula appears to be leaking as co2 levels cannot be detected on a dre ez wave line monitor.The cannula was changed out.The condition of the pt is reported as fine.

Manufacturer Narrative

The device sample was not returned for eval at the time of this report.A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.Dhr (device history record) reviewed showed that there were no issues related to this issue neither on the product nor its components during the manufacture of the material.A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause, in order to perform a proper investigation, it is necessary to evaluate the sample involved on the incident.Customer complaint cannot be confirmed based only on the info provided, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident.However current production was verified to identify any issue that can lead to the reported defect and no issues were found.If the defective sample becomes available this investigation will be updated with the eval results.

• Brand Name: HUDSON ETCO2 CANNULA, LARGE W/GAS SAMPLING LINE
• Type of Device: CANNULA W/ GAS SAMPLING LINE
• Manufacturer (Section D): TELEFLEX; nuevo laredo ; MX
• Manufacturer Contact: margie burton, rn ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3938074
• MDR Text Key: 19801677
• Report Number: 3004365956-2014-00145
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1845
• Device Lot Number: 02L1302135
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1