MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CO2 SAMPLING CANNULA A, 7FT 7FT, F; ANALYZER, GAS, CARBON-DIOXIDE,

Catalog Number 2844

Device Problem Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges "doctors report that they are not getting correct/no etco2 readings." it was reported there was no patient injury or consequence.

Manufacturer Narrative

Qn# (b)(4).The sample was returned and forwarded to the manufacturer (soundway/shengyurui medical) for investigation.Ups has reported that the sample was abandoned during transit to china and is unable to be located at this time.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

Customer complaint alleges "doctors report that they are not getting correct/no etco2 readings." it was reported there was no patient injury or consequence.

• Brand Name: HUDSON CO2 SAMPLING CANNULA A, 7FT 7FT, F
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE,
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8004711
• MDR Text Key: 124982095
• Report Number: 3011137372-2018-00289
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• PMA/PMN Number: K143469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2023
• Device Catalogue Number: 2844
• Device Lot Number: 171521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Date Manufacturer Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.