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

Model Number 738

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

It was reported that the fill port tube on a tpn therapy bag was found to be broken.The defect was discovered prior to the compounding process.This report documents no patient involvement or adverse events.No additional information is available.

Manufacturer Narrative

(b)(4).Evaluation summary: actual event date remains unknown.One sample was returned for inspection.The batch review found no indication of related nonconformance during the manufacture of this product.Visual and functional inspection confirmed the reported condition, which was determined to be related to the manufacture of the device.Manufacturing controls are in place to reduce the likelihood of recurrence.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: 4857340
• MDR Text Key: 5871872
• Report Number: 1419106-2015-00092
• Device Sequence Number: 1
• Product Code: KPE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Pharmacist
• Device Expiration Date: 05/30/2017
• Device Model Number: 738
• Device Catalogue Number: H938738
• Device Lot Number: 1001093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1