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

Catalog Number 2848

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

Customer complaint reported as: collapsing and cannot get a patient reading.Additional information was requested, but was not available at the time of this report.Issue for patient reading captured in 3011137372-2020-00139.

Event Description

Customer complaint reported as: collapsing and cannot get a patient reading.Additional information was requested, but was not available at the time of this report.Issue for patient reading captured in 3011137372-2020-00139.

Manufacturer Narrative

(b)(4).The sample was returned and sent to the manufacturer (soundway) for investigation.Soundway reports: "check dhr and first sample confirmation, no abnormality is found." "to check the returned sample, first releasing the cannula of the co2 line in the case of co2 line ventilation , visibly bubbles can be seen from the cannula.Then sealing the cannula of the co2 line, there is no air leakage , so the co2 line is qualified.Similarly , releasing the cannula in the case of the o2 line ventilation , visibly bubbles can be seen from the cannula.Then sealing the cannula of the o2 line, there is air leakage , so the o2 line is unqualified.Further examination for the returned sample , we found that the o2 line was cut where the air leakage." "during the process inspection, we perform 100% gas flow test.Meanwhile , check the production process , it is impossible to cut the tube.We also ask the customer to let us know if there is any possibility of using the tool during use , which may cut the tube accidentally.".

• Brand Name: HUDSON CO2 SOFTECH CANNULA A, 14FT 14FT, M
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE,
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10191758
• MDR Text Key: 196979229
• Report Number: 3011137372-2020-00138
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2848
• Device Lot Number: 191089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.