MAUDE Adverse Event Report: EWARDS LIFE SCIENCE PRESEP CATHETER 8.5, 16 CM LONG

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/18/2004

Event Type  malfunction  

Event Description

Presep central line catheter inserted; noted pulsatile blood backing up in catheter.Flushed with saline.Approximately 100 ml of blood seeped out of central line insertion site.Anesthesia present, removed catheter.Crack noted in catheter.Diagnosis or reason for use: for fluid infusion and monitoring svc02 for septic patient.

• Brand Name: PRESEP CATHETER 8.5, 16 CM LONG
• Type of Device: PRESEP CATHETER
• Manufacturer (Section D): EWARDS LIFE SCIENCE; irvine 92614
• MDR Report Key: 4199223
• MDR Text Key: 4983600
• Report Number: MW5038781
• Device Sequence Number: 1
• Product Code: DQE
• 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: 10/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 603