MAUDE Adverse Event Report: PORTEX

Model Number CA13E0/400/000JP

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2020

Event Type  malfunction  

Event Description

It was reported that during the use of a smiths medical anesthesia circuit , the customer noticed air was leaking from the product's anesthesia circuit.So he stopped using the product.No patient injury.

Manufacturer Narrative

Other, other text: device evaluation: one smiths medicalanesthesia circuit was returned for analysis in used condition without its original packaging.Visual inspection showed a tear in the circuit.Based on evidence and investigation, the complaint allegation was confirmed.A review of manufacturing processes was performed.It was verified that procedures in the assembly process were being properly followed.While no definitive problem source to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing one possible, but unconfirmed, problem source was listed as damage to the product after it left the smiths medical facility.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: PORTEX
• MDR Report Key: 10841492
• MDR Text Key: 217696098
• Report Number: 3012307300-2020-11460
• 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
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

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 Expiration Date: 10/18/2021
• Device Model Number: CA13E0/400/000JP
• Device Lot Number: 200715
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 11/15/2020
• Supplement Dates Manufacturer Received: 01/31/2021
• Supplement Dates FDA Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1