MAUDE Adverse Event Report: NULL PORTEX; ANESTHESIOLOGY

Model Number 4074041

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

One device was returned for investigation.The pinhole leak was confirmed.To try and duplicate the pinhole, the assembly and packaging process were duplicated and the failure mode could not be replicated using the tools from assembly and packaging process.Root cause could not be attributed to manufacturing process due to this.

Event Description

It was reported that during pre-test, an error was detected.No patient injury.

• Brand Name: PORTEX
• Type of Device: ANESTHESIOLOGY
• Manufacturer (Section G): NULL
• MDR Report Key: 13389292
• MDR Text Key: 286860724
• Report Number: 3012307300-2022-02141
• 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: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4074041
• Device Catalogue Number: C37101329
• Device Lot Number: 4074041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1