MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. 72 INCH LINE W/.2 FILTER

Model Number MXG300152

Device Problems Fracture (1260); Chemical Spillage (2894); Improper Flow or Infusion (2954)

Patient Problem No Information (3190)

Event Date 12/23/2013

Event Type  malfunction  

Event Description

Med tubing leaking around filter.Blood backed up from umbilical venous catheter (uvc).Fluids on floor and blood in the tubing when registered nurse went to check on the medical infusion.They subsequently pulled all medical tubing with this lot number off the floor.Will flush all tubing and watch medicine infusions closely.Lot#: 2561384 web event and flush all tubing before attaching to patients.

• Brand Name: 72 INCH LINE W/.2 FILTER
• Type of Device: FILTER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings rd.; dublin OH 43016
• MDR Report Key: 3580369
• MDR Text Key: 17838792
• Report Number: 3580369
• Device Sequence Number: 1
• Product Code: FPB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: MXG300152
• Device Catalogue Number: MXG300152
• Device Lot Number: 2561384
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 DAY