MAUDE Adverse Event Report: TELEFLEX MEDICAL ETCO2 CANNULA,LARGE W/GAS SAMPLING LINE; ANALYZER, GAS, CARBON-DIOXIDE

Catalog Number	RHET45U
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "when adding oxygen flow via the nasal cannula the etco2 waveform disappear." no patient harm, desaturation, or injury occurred.
Event or Problem Description
It was reported that "when adding oxygen flow via the nasal cannula the etco2 waveform disappear." no patient harm, desaturation, or injury occurred.
Additional Manufacturer Narrative
(b)(4).The actual sample was not returned; however, the customer provided photos for evaluation.Based on the evaluation of the photos provided the complaint could not be confirmed.The device history record of lot number 74d2300709 was reviewed, and no issues or discrepancies were found which could potentially be related to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.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.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).The sample was returned for investigation.A visual exam was performed on the returned device and it was observed that the device was assembled correctly.Functional testing was also performed and no issues were encountered.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.
Event or Problem Description
It was reported that "when adding oxygen flow via the nasal cannula the etco2 waveform disappear." no patient harm, desaturation, or injury occurred.

• Brand Name: ETCO2 CANNULA,LARGE W/GAS SAMPLING LINE
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17626901
• Report Number: 3004365956-2023-00063
• Device Sequence Number: 6118813
• Product Code: CCK
• UDI-Device Identifier: 14026704717870
• UDI-Public: 14026704717870
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K961150
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RHET45U
• Device Lot Number: 74D2300709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2023
• Supplement Date Received by Manufacturer: 09/01/2023; 10/18/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 09/13/2023; 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown