MAUDE Adverse Event Report: COVIDIEN LP ARGYLE; TUBING, NONINVASIVE

Model Number 8888301614

Device Problem Disconnection (1171)

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

Event Date 09/14/2017

Event Type  malfunction  

Event Description

Suction tubing attached to anesthesia machine was not connected to suction canister before cases in or room, i reconnected it prior to start of day.Upon emergence of anesthesia for first patient, i tried to suction patient's orally and tubing was disconnected.Twice within few minutes or nurse had to reconnect tubing to canister as it fell twice during emergence.Tubing has to be pushed on and twisted and still can fall off elbow connection on canister.

• Brand Name: ARGYLE
• Type of Device: TUBING, NONINVASIVE
• Manufacturer (Section D): COVIDIEN LP; karin desjardins; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 7027661
• MDR Text Key: 91916280
• Report Number: 7027661
• Device Sequence Number: 1
• Product Code: GAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888301614
• Device Catalogue Number: 8888301614
• Other Device ID Number: 2310
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1