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

Model Number 741

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event unknown.Initially, this was reported as a duplicate case, but an additional sample was returned and evaluated at a later date.The batch review did not find any nonconformances related to the reported condition during the manufacture of this device.The visual inspection identified the reported issue and confirmed that the fill port tubing had been damaged, resulting in the fill port connector/cap assembly being removed.The damage to the fill port tubing was determined to have been caused by the tubing being misaligned in the manufacturing equipment during fill port installation.Manufacturing controls are in place to reduce the likelihood of recurrence of this defect including startup and 100% final visual inspection, as well as in process inspection.Should additional relevant information become available, a follow-up report will be submitted.

Event Description

It was reported that the fill port of the tpn therapy bag was found to be mangled or crushed after being removed from the outer wrap.There was no patient involvement or adverse event reported.No additional information is available.

• 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: thuy nguyen ; 9540 s maroon circle; suite 400; englewood, CO 80112
• MDR Report Key: 5481562
• MDR Text Key: 39746722
• Report Number: 1419106-2016-00136
• 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: company representative,health
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/13/2018
• Device Model Number: 741
• Device Catalogue Number: H938741
• Device Lot Number: 1083274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1