MAUDE Adverse Event Report: NULL PORTEX GENERAL ANESTHESIA CIRCUITS; ANESTHESIA CONDUCTION KIT

Catalog Number C45101340-NLJ

Device Problem Component Missing (2306)

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

Event Date 05/15/2020

Event Type  malfunction  

Event Description

It was reported that before opening the package, the customer noticed no elbow connector was attached to the anesthesia circuit.No patient injury was reported.

Manufacturer Narrative

Udi information is unknown.Operator of device is unknown.No information has been provided to date.Manufacturing site address is unknown.Premarket (510k) number is unknown.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.It was found that the sample did not have an elbow connector.The most probable root cause is: the elbow fell after it was assembled, and production personnel did not detect the missing component.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section G): NULL
• MDR Report Key: 15433508
• MDR Text Key: 304811471
• Report Number: 3012307300-2022-19337
• Device Sequence Number: 1
• Product Code: CAZ
• 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: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 01/16/2023
• Device Catalogue Number: C45101340-NLJ
• Device Lot Number: 3930793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1