MAUDE Adverse Event Report: BAXTER HEALTHCARE - AIBONITO ACCESS; FILTER, INFUSION LINE

Catalog Number 2N3342

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

During product evaluation, it was identified that an interlink extension set had brown spots in the filter.No additional information is available.

Manufacturer Narrative

(b)(4).Evaluation summary: visual inspection revealed brown spots in the filter of the device.Functional testing was performed, and the device operated per specification.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.

• Brand Name: ACCESS
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3; po box 1389; aibonito PR 0070 5
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3; po box 1389; aibonito PR 0070 5
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3602835
• MDR Text Key: 4070019
• Report Number: 1416980-2014-03128
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K113227
• 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
• Report Date: 01/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/23/2017
• Device Catalogue Number: 2N3342
• Device Lot Number: UR12J23032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2013
• Date Manufacturer Received: 01/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2012
• 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
• Treatment: TOTAL PARENTERAL NUTRITION (TPN)