MAUDE Adverse Event Report: NULL PORTEX GENERAL ANESTHESIA CIRCUITS; BREATHING CIRCUITS.

Catalog Number CA17K0/000/004JP

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2021

Event Type  malfunction  

Manufacturer Narrative

One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.The root cause may be due to manufacturing.Dhr review was completed.Review of manufacturing records, relevant to the lot reported, found no discrepancies or anomalies.

Event Description

It was reported that during the pre-use check, a leak was noted.A hole (or a pinhole) was found in the corrugated tube.No patient injury.No additional information is available.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: BREATHING CIRCUITS.
• Manufacturer (Section G): NULL
• MDR Report Key: 13227776
• MDR Text Key: 284015641
• Report Number: 3012307300-2022-00303
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2022

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: Health Professional
• Device Catalogue Number: CA17K0/000/004JP
• Device Lot Number: 211101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1