MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CO2 SAMPLING CANNULA A, 14FT 14FT, M; ANALYZER, GAS, CARBON-DIOXIDE,

Catalog Number 2848

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has been received by the manufacturer.However, the investigation of said device is still in progress at the time of this report.A follow up report will be submitted upon completion of the device evaluation.

Event Description

Customer complaint alleges they found the sampling ports were blocked.Alleged defect reported as detected during an "endo" procedure.Customer reports there was no patient harm.

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.A visual exam and functional testing were performed and no issues were found.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.

Event Description

Customer complaint alleges they found the sampling ports were blocked.Alleged defect reported as detected during an "endo" procedure.Customer reports there was no patient harm.

• Brand Name: HUDSON CO2 SAMPLING CANNULA A, 14FT 14FT, M
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE,
• 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: 6929271
• MDR Text Key: 89503752
• Report Number: 3011137372-2017-00297
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143469
• 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: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/07/2022
• Device Catalogue Number: 2848
• Device Lot Number: 170524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2017
• 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