MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ANESTHESIA CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) PRODUCT CODE: CAI

Catalog Number CA13E0/400/000JP 

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 04/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Information was received that the elbow connector on a smiths medical portex anesthesia circuit set was deformed, this was discovered during a pre-use check.No patient involvement.

Manufacturer Narrative

One breathing general anesthesia circuit was returned for evaluation.Visual inspection of the device found the elbow connector to be deformed.Device functional testing resulted in no connection able to be made to the leak tester confirming the reported customer complaint.The documents for assembly of disposable anesthesia breathing circuit, and quality procedure for disposable anesthesia breathing circuit were reviewed.Production personnel performs a 100 percent leak test on the leak tester using calibrated flow meters to measure the air outlet.During the test, if the elbow connector is deformed or damaged the unit failed the test.The most probable cause of the issue was determined to be that damage occurred after the product left smiths medical facility.

• Brand Name: PORTEX ANESTHESIA CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) PRODUCT CODE: CAI
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8602514
• MDR Text Key: 144810046
• Report Number: 3012307300-2019-02596
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2022
• Device Catalogue Number: CA13E0/400/000JP
• Device Lot Number: 3772408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• Date Manufacturer Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly