MAUDE Adverse Event Report: BAXTER HEALTHCARE - IRVINE FOLFUSOR; PUMP, INFUSION, ELASTOMERIC

Catalog Number 2C4711K

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 09/18/2014

Event Type  malfunction  

Event Description

It was reported that a small volume folfusor was cracked at the injection port.This was found before use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Complaint no: (b)(4).This lot was manufactured from november 6, 2013 to november 7, 2013.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not returned; therefore, a device analysis could not be completed.Should additional relevant information become available, a follow-up mdr will be submitted.

• Brand Name: FOLFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; bldg 3; irvine CA 92614
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; bldg 3; irvine CA 92614
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 4167360
• MDR Text Key: 5027513
• Report Number: 1416980-2014-35673
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/18/2014

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: Other
• Device Expiration Date: 11/01/2015
• Device Catalogue Number: 2C4711K
• Device Lot Number: 13M023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2014
• Initial Date FDA Received: 10/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1