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

Model Number 30893-07

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 04/26/2018

Event Type  malfunction  

Event Description

The epidural tubing failed.It started leaking at the hub on the patient's side of the tubing.This is the 3rd reported failure of this lot number.

• Brand Name: ALARIS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 7510722
• MDR Text Key: 108169541
• Report Number: 7510722
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403460234
• UDI-Public: (01)10885403460234
• 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: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 30893-07
• Device Catalogue Number: 30893-07
• Device Lot Number: 17126893
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/01/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2018
• 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
• Treatment: NO OTHER THERAPIES.