MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. TRANSTAR KIDS KITS; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number MXG300271

Device Problems Difficult to Insert (1316); Dull, Blunt (2407)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/22/2018

Event Type  malfunction  

Event Description

Unable to insert blunt cannula into access device of kids kit.Attempted multiple blunt cannula devices to ensure it wasn't the cannulas that were defective.Ended up having to change out the entire kids kit and line set up.The new kids kit was able to be accessed.Manufacturer response for transtar kids kit w/30cc flush and color "stip", (brand not provided) (per site reporter).

• Brand Name: TRANSTAR KIDS KITS
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• MDR Report Key: 8178745
• MDR Text Key: 130924399
• Report Number: 8178745
• Device Sequence Number: 1
• Product Code: DRS
• 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: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MXG300271
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/13/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1