MAUDE Adverse Event Report: NULL

Lot Number 200408

Device Problems Fluid/Blood Leak (1250); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2020

Event Type  malfunction  

Event Description

Information received a smiths medical portex epidural custom continuous needle, while infusing medical fluid through the epidural filter during an anesthesia, the customer felt resistance back from the filter.Also, leakage of medical fluid from the epifuse connector was observed.No patient injury.

• Manufacturer (Section G): NULL
• MDR Report Key: 10260956
• MDR Text Key: 199452825
• Report Number: 3012307300-2020-07177
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 200408
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1