MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX® DISPOSABLE ANESTHESIA BREATHING CIRCUIT; ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)

Catalog Number C45091342-NLJ

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2019

Event Type  malfunction  

Event Description

Information was received indicating that an air leak alarm occurred following connecting a smiths medical portex® disposable anesthesia breathing circuit to an anesthesia device.There were no reported adverse patient effects.

Manufacturer Narrative

One sample was returned for evaluation.Visual inspection of the device found it to be in good physical condition.The circuit underwent functional testing; device was noted to be leaking.The customer complaint has been confirmed, and the problem source has been determined to be manufacturing.

• Brand Name: PORTEX® DISPOSABLE ANESTHESIA BREATHING CIRCUIT
• Type of Device: ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 9613564
• MDR Text Key: 180317496
• Report Number: 3012307300-2020-00296
• Device Sequence Number: 1
• Product Code: OFP
• Combination Product (y/n): N
• 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: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: C45091342-NLJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/25/2019
• Date Manufacturer Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1