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

Catalog Number 2845

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported the cannula became kinked during use in the operating room.The issue was detected when the machine alarmed.No patient harm reported.

Event Description

Customer reported the cannula became kinked during use in the operating room.The issue was detected when the machine alarmed.No patient harm reported.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.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.

• Brand Name: HUDSON CO2 SOFTECH CANNULA A, 7FT 7FT, M
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE,
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9545032
• MDR Text Key: 190850098
• Report Number: 3011137372-2020-00001
• 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: 12/13/2019

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
• Device Operator: No Information
• Device Catalogue Number: 2845
• Device Lot Number: 1823351
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: 01/15/2020
• Supplement Dates FDA Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED