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

Catalog Number 2C4009K

Device Problems Device Packaging Compromised (2916); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The lot 13n010 was manufactured between december 10, 2013 and december 11, 2013.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).An affirmative statement of product nonconformance can be made as the affected unit manifested the complaint's allegation of particulate matter.The origin and time in which this particulate became present cannot be determined with the provided information.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was a hair inside the packaging of a large volume folfusor.This was noted before patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).(b)(6).The device was received for evaluation in its original sealed and unopened overpouch.Visual inspection revealed a 3 inch long strand of black hair in the overpouch.The hair was not in the fluid path.The reported condition was confirmed.Baxter has conducted a trend review and found that similar reports have been received for the reported problem.Baxter will continue to monitor similar reports to determine if further actions are required.A batch review will be performed.Should additional relevant information become available, a supplemental report 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: 3679835
• MDR Text Key: 11881103
• Report Number: 1416980-2014-08631
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2014

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: 12/01/2015
• Device Catalogue Number: 2C4009K
• Device Lot Number: 13N010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2014
• Initial Date FDA Received: 03/14/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/02/2014; 06/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2013
• 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