MAUDE Adverse Event Report: PORTEX; OXYGEN AEROSOL TUBING

Catalog Number 001860

Device Problems Leak/Splash (1354); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2020

Event Type  malfunction  

Event Description

Information was received that when connecting an anesthesia device to the product at a pre-use check, the customer noticed air was leaking from it.The corrugated tube was checked, and noted to be partially deformed.A hole was seen at that part.No patient injury.

Manufacturer Narrative

Other, other text: h10 - device evaluation results: the affected product (portex oxygen/aerosol tubing) was returned for investigation in used condition.Six photographs of the product were also returned.The photographs showed that the circuit had a tear.The physical device was then visually inspected at a distance of 12 inches under normal lighting conditions.The tear shown in the photographs was confirmed.A manufacturing problem was established as the root cause of the tear.

• Brand Name: PORTEX
• Type of Device: OXYGEN AEROSOL TUBING
• MDR Report Key: 10587679
• MDR Text Key: 208573815
• Report Number: 3012307300-2020-09822
• Device Sequence Number: 1
• Product Code: OFP
• 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: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 001860
• Device Lot Number: 4004752
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1