MAUDE Adverse Event Report: BAXTER HEALTHCARE ¿ ROUND LAKE 250 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938737

Device Problem Fluid/Blood Leak (1250)

Patient Problem Premature Labor (2465)

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

The user facility submitted a medwatch report for this event: mw5083495.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a 250ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag leaked around the tubing spike port.The device was filled with 145ml of unspecified solution.The leak was noted during filling.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was manufactured between july 10, 2018 - july 11, 2018.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.

• Brand Name: 250 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE ¿ ROUND LAKE; round lake IL
• MDR Report Key: 8409411
• MDR Text Key: 138712866
• Report Number: 1416980-2019-01322
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477213
• UDI-Public: (01)00085412477213
• Combination Product (y/n): N
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: H938737
• Device Lot Number: 60137708
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/11/2019
• Supplement Dates Manufacturer Received: 04/12/2019
• Supplement Dates FDA Received: 04/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1