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 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that six (6) 2000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags were leaking ¿from where the administration port is sealed to the bag¿.The leaks were discovered after compounding prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Lot manufactured between april 16, 2020 to april 20, 2020.The actual devices were not available; therefore a device analysis could not be completed for those samples.However, forty-three (43) companion samples were received for evaluation.Visual inspection of the companion samples did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed on five (5) random samples which revealed a leak at the spike port bonding area of all 5 samples.The reported condition of leak was verified on the companion samples.The cause could not be determined, however, the cause was most likely due to inadequate or lack of cyclohexanone applied during 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: 2000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10588521
• MDR Text Key: 208601441
• Report Number: 1416980-2020-06002
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• 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: H938740
• Device Lot Number: 60236626
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1