MAUDE Adverse Event Report: WESTMED, INC. DISPOSABLE ANESTHESIA BREATHING CIRCUIT; ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)

Catalog Number 8022

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/09/2019

Event Type  malfunction  

Event Description

The patient was to undergo a tympanoplasty.Prior to induction, her lungs were clear.After intubation, the patient was difficult to oxygenate.She had recently had bronchitis and was still using albuterol intermittently.The anesthesia team initially thought the patient was having bronchospasms or laryngospasms, and treated both with no effect.They suctioned her, and upon cleaning the anesthesia circuit, discovered a clear plastic syringe cap wedged in the circuit.The circuit was immediately changed out with improvement in the patient's spo2.The procedure was aborted, and the patient was admitted overnight for observation.Subsequent to this event, the staff checked the supply of circuits and found a second circuit with a cap in the elbow.The packaging from the event was not saved so we do not know if it's from the same lot number.However, the lot number from the second package found is 120618t89.Subsequent to the event, the staff found a 2nd circuit with the cap in the elbow.

• Brand Name: DISPOSABLE ANESTHESIA BREATHING CIRCUIT
• Type of Device: ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)
• Manufacturer (Section D): WESTMED, INC.; 5580 s nogales hwy; tucson AZ 85706
• MDR Report Key: 8925304
• MDR Text Key: 155343620
• Report Number: 8925304
• Device Sequence Number: 1
• Product Code: OFP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8022
• Device Lot Number: 120618T89 (2ND DEVICE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2019
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 10585 DA