MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTAMIX EVA BAG; EVA TPN BAG

Model Number 740

Device Problem Cut In Material (2454)

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

Event Date 03/11/2015

Event Type  malfunction  

Event Description

It was reported that a tpn therapy bag was found to have a cut in the upper half of the bag.The cut was discovered prior to beginning the compounding process.The potential hazard is that the bag would be used for compounding and the cut would produce a leak.This report documents no patient involvement or adverse events.No additional information is available.

Manufacturer Narrative

(b)(4).Evaluation summary: one sample was returned for evaluation.The batch review found no indication of related nonconformance during the manufacture of this product.The visual inspection identified a surface gouge on the rear face of the eva.The cause of the condition remains unknown.Should additional relevant information become available, a follow-up report will be submitted.

• Brand Name: EXACTAMIX EVA BAG
• Type of Device: EVA TPN BAG
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 14445 grasslands drive; englewood CO 80112
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; 14445 grasslands drive; englewood CO 80112
• Manufacturer Contact: eric cops ; 9540 s. maroon circle, ste 400; englewood, CO 80112 ; 3033909774
• MDR Report Key: 4674535
• MDR Text Key: 22246461
• Report Number: 1419106-2015-00045
• Device Sequence Number: 1
• Product Code: KPE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/19/2017
• Device Model Number: 740
• Device Catalogue Number: H938740
• Device Lot Number: 1021695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2014
• 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