MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 3000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938741

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a 3000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag leaked from a hole located in front the bag.It was further reported that approximately 200ml had leaked from the bag.This issue was identified during setup and preparation prior to patient use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information was added to d9, h3, h4 and h6.H4: the lot was manufactured from april 23, 2020 - april 28, 2020.H10: the device was received for evaluation.A visual inspection was performed, and it was noted that there was a tear in the upper middle front side of the bag.Functional testing was performed which revealed a leak from affected area at the top middle area in front of the bag.Additional magnified inspection was performed which verified a tear/hole where the leak occurred.The reported condition was verified.The cause of the condition could not be determined; however, the possible causes of the tear/hole was due to compounding error, damage sustained during transport, or during customer handling.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: 3000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11349314
• MDR Text Key: 232589875
• Report Number: 1416980-2021-00747
• Device Sequence Number: 1
• Product Code: LHI
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

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: Lay User/Patient
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: H938741
• Device Lot Number: 60238463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• 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: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1