MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PRESSURE MONITORING: MEDEX; TRANSTAR KIDS KITS / ARTERIAL BLOOD SAMPLING KIT

Device Problems Difficult to Flush (1251); Leak/Splash (1354); Device Contamination with Body Fluid (2317)

Patient Problem No Information (3190)

Event Date 11/28/2018

Event Type  Injury  

Event Description

Four accounts of product issues: transtar kids kit 31" closed blood sample kit (iv tubing), noted to have blood under rubber stopper (should not have blood there); the nurse for the pt accessed the umbilical arterial catheter to draw labs, when trying to flush the line and return the wasted blood, the line would not flush and blood appeared to be around the port of the transducer; stop cock on transducer of umbilical artery line found with blood in an inappropriate location.New fluids and tubing hung; in trying to replicate the above issues with an unused product, noted to have in the system and there was active leaking / bubbling of fluid (fake blood was used).

• Brand Name: PRESSURE MONITORING: MEDEX
• Type of Device: TRANSTAR KIDS KITS / ARTERIAL BLOOD SAMPLING KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 8191301
• MDR Text Key: 131466376
• Report Number: MW5082494
• Device Sequence Number: 3
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/19/2018
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention