MAUDE Adverse Event Report: BAXTER HEALTHCARE ¿ ROUND LAKE 4000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938742

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a 4000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was leaking on the side seam, half of a foot up from the bottom.This event occurred before use of the device.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Upon further investigation, it was determined that this report is a duplicate of report of 1416980-2018-07902.All investigation activities will be captured under report 1416980-2018-07902.

• Brand Name: 4000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE ¿ ROUND LAKE; round lake IL
• Manufacturer (Section G): BAXTER HEALTHCARE ¿ ROUND LAKE; 25212 w. illinois route 120; round lake IL 60073
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8185726
• MDR Text Key: 131063903
• Report Number: 1416980-2018-07943
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477268
• UDI-Public: (01)00085412477268
• 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,Followup
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: H938742
• Device Lot Number: 1232229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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