MAUDE Adverse Event Report: ST PAUL PORTEX DISPOSABLE ANESTHESIA CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number C37101329-NLJJP

Device Problems Leak/Splash (1354); Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2020

Event Type  malfunction  

Event Description

Information was received indicating that during pre-use check, a smiths medical portex disposable anesthesia circuit was found to have an air leak.There were no reported adverse effects.

Manufacturer Narrative

Two portex general anesthesia circuits were received in used conditions.No discrepancies noted upon visual inspection.Functional testing performed using a gauge; circuits did not pass the leak tests.The manufacturing process was then reviewed and deemed adequate.During the audit it was seen that production personnel perform leak testing.However, during the functional testing, the corrugated tube was broken; failing the test.After the leak test, visual inspection was performed on the same samples to verify any damage on the components.A random sample of 32 units was taken from the manufacturing process to verify that there was no damage; free from damage.Based on the evidence, the complaint was confirmed.The root cause was found due to manufacturing.

• Brand Name: PORTEX DISPOSABLE ANESTHESIA CIRCUITS
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10128788
• MDR Text Key: 194335770
• Report Number: 3012307300-2020-05634
• 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: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: C37101329-NLJJP
• Device Lot Number: 3921225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/08/2020
• Supplement Dates Manufacturer Received: 07/07/2020
• Supplement Dates FDA Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1