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

Catalog Number H938739

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a 1000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag leaked from the additive port.The leak was discovered during mixing prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d9, h3, h4 and h6.H10: the device was received for evaluation.Visual inspection was performed which observed a tear/hole in the back side of the bag.A functional testing was performed which revealed a leak in the affected area.The leak from the additive port was not verified.The cause of the tear/hole could not be determined.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.

• Brand Name: 1000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11339905
• MDR Text Key: 232414793
• Report Number: 1416980-2021-00709
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477237
• UDI-Public: (01)00085412477237
• Combination Product (y/n): Y
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

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: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: H938739
• Device Lot Number: 60232901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1