MAUDE Adverse Event Report: CAREFUSION 303, INC. MAXGUARD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MXT1003

Device Problems Air Leak (1008); Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 04/25/2017

Event Type  malfunction  

Event Description

While starting an iv and obtaining blood sample from patient, blood was noticed to be leaking from the first hub and air bubbles noted to tubing.Nurse did not flush the iv tubing due to potential contamination.Iv tubing was changed and flushed without difficulty.This is the second time this has happened in the pediatric er, first time was not documented.Blood cultures were obtained.

• Brand Name: MAXGUARD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 6633427
• MDR Text Key: 77316539
• Report Number: 6633427
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2017,04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 12/19/2021
• Device Model Number: MXT1003
• Device Catalogue Number: MXT1003
• Device Lot Number: 16127113
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1