MAUDE Adverse Event Report: ICU MEDICAL, INC. TRANSPAC TRIFURCATED MONITORING KIT WITH SAFESET RESERVOIR; TRANSDUCER, BLOOD PRESSURE, EXTRAVASCULAR

Model Number 42650-06

Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907)

Patient Problem Exposure to Body Fluids (1745)

Event Date 11/14/2018

Event Type  Injury  

Event Description

Upon pulling a blood sample from the integrated syringe, the black rubber plunger became disconnected from the syringe plunger.A specimen was unable to be pulled and blood leaked out behind the syringe plunger and out the plunger hole onto the user's hands.The black rubber piece was able to be attached back to the plunger.

• Brand Name: TRANSPAC TRIFURCATED MONITORING KIT WITH SAFESET RESERVOIR
• Type of Device: TRANSDUCER, BLOOD PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; san clemente CA 92673
• MDR Report Key: 8079275
• MDR Text Key: 128030134
• Report Number: MW5081394
• Device Sequence Number: 1
• 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: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: 42650-06
• Device Lot Number: 3748023
• Was Device Available for Evaluation?: Yes
• 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