MAUDE Adverse Event Report: ICU MEDICAL TRANSPAC IV MONITORING KIT WITH 24 INCH TUBING - 3MM INTRAFLOW FLU; SAFE SET

Catalog Number RI 46103-68

Device Problems Fluid/Blood Leak (1250); Sticking (1597)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

The safe set reservoir - needleless valve when accessed for blood draw - blood came out of needleless valve when tubing flushed - valve stuck in down - open position.Diagnosis or reason for use: arterial blood pressure monitoring and blood draws.

• Brand Name: TRANSPAC IV MONITORING KIT WITH 24 INCH TUBING - 3MM INTRAFLOW FLU
• Type of Device: SAFE SET
• Manufacturer (Section D): ICU MEDICAL; 951 calle amanecer; CA 92673
• MDR Report Key: 3777506
• MDR Text Key: 4435709
• Report Number: MW5035804
• Device Sequence Number: 1
• Product Code: DRS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RI 46103-68
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention