MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 2000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938740

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that an unspecified quantity of 2000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags leaked coming from the 2 end seals on the ports.It was stated that the bag ¿was only sealed by the ports, the sides were not sealed at all¿.The leaks were discovered during setup and preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d4 lot # and expiration date (upon follow up, customer clarified information), d9, h3, h4 and h6.H4: the lot was manufactured october 29, 2020 to october 31, 2020.H10: the device was received for evaluation.Unaided visual inspection observed an incomplete sealing defect at the lower right and left port sides of the bag located at the shoulder port weld.Functional testing was performed using tap water which observed a large leak from the unsealed bottom right and left sides of the ports at the shoulder port weld areas.The reported condition was verified.The cause of the condition could not be determined; however, the most likely cause was due to a variation in the manufacturing equipment weld process.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: 2000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11352579
• MDR Text Key: 233032230
• Report Number: 1416980-2021-00772
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477244
• UDI-Public: (01)00085412477244
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

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: Other
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: H938740
• Device Lot Number: 60266057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 03/10/2021
• Supplement Dates FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1