MAUDE Adverse Event Report: INTERSURGICAL UAB BREATHING SYSTEM; AIRWAY, OROPHARYNGEAL

Model Number 2901000

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2020

Event Type  Injury  

Manufacturer Narrative

The problem had been caused by breakage of 7024 universal f inner swivel connector, which connects the inner tube to the t-piece at the machine end.No signs of mechanical impact found when visually inspecting returned sample.The tests carried out at the manufacture include separate leakage testing of the inner and outer tubes therefore we believe the connector did brake after the system was assembled and packed.The issue had to be identified during the pre use checks when testing the inner tube for leakage.A red inner lumen leak tester with the instruction how to use it is in the bag for this purpose.It is the first report regarding this type of defect for this product code since 2017.No products from the same lot in the stock.It is an extremely rare occurrence, with the failure rate less than (b)(4).

Event Description

Patient was asleep and the anaesthetist notice the co2 level was not right so on further investigation he found the faulty circuit and changed it in around a couple on minutes.No harm as circuit replaced.The white sleeve on the tee piece connector has come away from the coaxial breathing circuit tube.

• Brand Name: BREATHING SYSTEM
• Type of Device: AIRWAY, OROPHARYNGEAL
• Manufacturer (Section D): INTERSURGICAL UAB; arnioniu 60/28-1; pabrade, ; LH
• Manufacturer Contact: ivan seniut ; arnioniu 60/28-1; pabrade, vilniaus apskritis, lt-4710 ; LH
• MDR Report Key: 10443087
• MDR Text Key: 212343836
• Report Number: 1319447-2020-00004
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2901000
• Device Lot Number: 31960115
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 1 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR