MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; TUBING, FLUID DELIVERY

Model Number MX43660

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problems Therapeutic Response, Decreased (2271); Blood Loss (2597)

Event Date 06/20/2020

Event Type  Injury  

Event Description

A hairline crack in the three-way stopcock attached to a umbilical vein catheter (uvc) line was found.At the time, the patient was receiving cardiac infusions.Blood was found leaking.As a result, the patient required immediate transfusion and increased dosage of cardiac infusions.

• Brand Name: MEDEX
• Type of Device: TUBING, FLUID DELIVERY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• MDR Report Key: 10275380
• MDR Text Key: 198868737
• Report Number: 10275380
• Device Sequence Number: 1
• Product Code: FPK
• 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: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MX43660
• Device Lot Number: 3912603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention