MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; FILTER, INFUSION LINE

Model Number MX448HFB

Device Problems Break (1069); Leak/Splash (1354); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 08/07/2022

Event Type  malfunction  

Event Description

Patient connected to 1l bolus of normal saline in hallway bed across from nurse¿s station.While infusing, defective iv tubing broke in half about 5 inches from hub connection to the patient.Fluid leaked out onto floor and blood into tubing still connected to patient.Break was noticed immediately and tubing was disconnected.Fluids cleaned up and properly disposed of.No harm to patient, iv catheter undamaged and remained intact.

• Brand Name: MEDEX
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 16022541
• MDR Text Key: 305890958
• Report Number: 16022541
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MX448HFB
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1