MAUDE Adverse Event Report: NULL PORTEX; BREATHING-CIRCUIT

Model Number CA13B0/400/000JP

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 11/01/2020

Event Type  malfunction  

Manufacturer Narrative

Returned device was received for evaluation.During the evaluation of the device the customer reported condition was not confirmed.No fault found.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

Event Description

It was reported that during a pre-use check, the customer noticed air was leaking from a smiths medical breathing circuit.So he did not use it.No patient injury.

• Brand Name: PORTEX
• Type of Device: BREATHING-CIRCUIT
• Manufacturer (Section G): NULL
• MDR Report Key: 10999621
• MDR Text Key: 221227800
• Report Number: 3012307300-2020-12324
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CA13B0/400/000JP
• Device Lot Number: 200911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1