MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. ADULT DISPOSABLE ANESTHESIA BREATHING CIRCUIT; CIRCULATOR, BREATHING-CIRCUIT

Catalog Number CA24B0/4P6/000JP

Device Problem Leak/Splash (1354)

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

Event Date 09/01/2018

Event Type  Injury  

Event Description

Information was received that during the use of a smiths medical breathing circuit, water droplets stayed in the connector for the hme filter, within the circuit ahead of the connector, and in the gas sampling line.No patient injury resulted.

Manufacturer Narrative

One photo of the device was received.Upon visual inspection of the photo, water in the circuit was confirmed.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: ADULT DISPOSABLE ANESTHESIA BREATHING CIRCUIT
• Type of Device: CIRCULATOR, BREATHING-CIRCUIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7997381
• MDR Text Key: 124963283
• Report Number: 3012307300-2018-01911
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CA24B0/4P6/000JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Date Manufacturer Received: 10/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1