MAUDE Adverse Event Report:; ANESTHESIA CONDUCTION KIT

Model Number NCE6145

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2020

Event Type  malfunction  

Event Description

It was reported that medical fluid was leaking from the product during a one-shot infusion on a smiths medical, device.The customer then noticed the epidural filter was broken and the leakage occurred in it.No adverse patient effects were reported.The reported part number is nce6145.

• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10019854
• MDR Text Key: 189695340
• Report Number: 3012307300-2020-03627
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NCE6145
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2020
• 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: Unknown
• Patient Sequence Number: 1