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

Catalog Number C37101330-NLJ

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation in progress.(b)(6).

Event Description

It was reported that during a pre-use check, leakage (air) was observed with the portex general anesthesia circuit.No patient injury or complications were reported in relation to this event.

Manufacturer Narrative

Other, other text: h3: two pictures of portex general anesthesia breathing circuit was received and it could be observed that the circuit had a tear on the circuit surface.One sample of the portex general anesthesia breathing circuit was received with its original package opened from part number c37101330-nlj with an unknown lot number.The sample was visually inspected at a distance of 12? under normal lighting to received unit.A tear was observed.The returned sample was tested according to failure mode reported and following the manufacturing procedure using leak tester lt-4-2-072, and the pressure gauge that was used.After the leak test was performed, the leak was confirmed.Based on the sample provided and the physical evaluation, the most probable cause is that the product became damaged after it left the manufacturing facility.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 11151070
• MDR Text Key: 226223060
• Report Number: 3012307300-2021-00262
• 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: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: C37101330-NLJ
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1