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

Catalog Number H938739

Device Problems Fluid/Blood Leak (1250); Component Misassembled (4004)

Patient Problem No Patient Involvement (2645)

Event Date 11/18/2020

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 port.The leak was discovered during compounding.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Correction to b5, f10/h6: device codes (add 4004).B5: additionally, it was further reported the port was on the outside of the container, causing a small spill on the machine.H4: the lot was manufactured from april 29, 2020 - may 08, 2020.H10: the device was received for evaluation.Unaided visual inspection was performed which observed that the fill port top end of the tubing was detached from the bag sticking outside in back of the bag.The reported condition was verified.The cause of the condition could not be determined; however, the most likely cause was due to the manufacturing 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: 1000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11008330
• MDR Text Key: 221752317
• Report Number: 1416980-2020-07769
• 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: 01/14/2021

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: 03/31/2023
• Device Catalogue Number: H938739
• Device Lot Number: 60239255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 01/12/2021
• Supplement Dates FDA Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1