MAUDE Adverse Event Report: NULL; PORTEX GENERAL ANESTHESIA CIRCUITS

Lot Number 3921223

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

One sample and three photos were received for evaluation.A device history record (dhr) review was performed which indicated all inspections were completed and no non conformances were identified during manufacture.Visual testing was performed and the reported issue was confirmed.A tear was observed on the device during visual inspection.During functional testing, the device did not pass the leak test.The confirmed issue is a known issue and has been investigated in a corrective and preventative action.Manufacturing controls and instructions for use (ifu) are in place to help prevent occurrence of the reported issue.No product information has been provided to date.D5 is unknown.No information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

Event Description

It was reported that during the use of the product, the customer found a pinhole in the anesthesia bag.There was no patient harm reported.

• Type of Device: PORTEX GENERAL ANESTHESIA CIRCUITS
• Manufacturer (Section G): NULL
• MDR Report Key: 15411232
• MDR Text Key: 306178863
• Report Number: 3012307300-2022-18961
• 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: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 01/22/2023
• Device Lot Number: 3921223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1