MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC PORTEX GENERAL ANESTHESIA CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number C1034J

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2019

Event Type  malfunction  

Event Description

It was reported that the product could not pass a pre-use air leak check.The customer suspected an occlusion.Also, the customer als felt that the connection was loose even though it was connecting with the anesthesia device.

Manufacturer Narrative

One (1) product from p/n (b)(4) , l/n unknown, the sample was received in used condition.During visual inspection it was concluded that the sample had a tear.During functional test, the sample did not pass the leak test.The customer reported condition was confirmed.Problem source is related to manufacturing.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8750759
• MDR Text Key: 149714461
• Report Number: 3012307300-2019-02967
• Device Sequence Number: 1
• Product Code: CAI
• 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: 09/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/12/2022
• Device Catalogue Number: C1034J
• Device Lot Number: 3772406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Date Manufacturer Received: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1