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

Catalog Number C37101307J

Device Problem Gas/Air Leak (2946)

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

Event Date 07/22/2020

Event Type  malfunction  

Manufacturer Narrative

Three pictures were received for investigation along with one used sample to perform an investigation.A visual inspection of the pictures did not observe leakage, cracks, or tears in the product.The sample was visually inspected at a distance of 12 inches under normal lighting conditions from the device and no visual defects could be observed.Functional testing of the device was performed by using a leak tester and gauge tester.The device passed the leak test.The reported problem was unable to be confirmed.No root cause could be determined as the complaint could not be confirmed.A device history record (dhr) review was conducted on the lot number of the returned product which indicated all inspections were completed and no issues were noted during manufacture.The reported manufacture and expiration date are based on the returned lot 4049358.A corrective and preventive action (capa) was initiated to address this issue.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms #: (b)(4).

Event Description

It was reported that during a hospital pre-use check, leakage of air from the anesthesia circuit was detected.No patient injury was reported.

• Brand Name: PORTEX DISPOSABLE ANESTHESIA BREATHING CIRCUITS
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section G): NULL
• MDR Report Key: 15595927
• MDR Text Key: 307111373
• Report Number: 3012307300-2022-20058
• Device Sequence Number: 1
• Product Code: CAI
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/03/2023
• Device Catalogue Number: C37101307J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1