MAUDE Adverse Event Report: BAXTER HEALTHCARE - ENGLEWOOD 1000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938739

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 11/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The device was received for evaluation in the factory packaging.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified.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.

Event Description

It was reported that an exactamix tpn bag contained ¿string like particles¿.This was observed after filling the bag with solution.There was no patient involvement.No additional information is available.

• Brand Name: 1000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE - ENGLEWOOD; englewood CO
• Manufacturer (Section G): BAXTER HEALTHCARE - ENGLEWOOD; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6179195
• MDR Text Key: 62540417
• Report Number: 1416980-2016-18412
• Device Sequence Number: 1
• Product Code: LHI
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: H938739
• Device Lot Number: 1153568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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