MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 500 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938738

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This event occurred during the unspecified date of (b)(6) 2020.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the unspecified quantity of 500ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags leaked from "the middle port on the bottom of the bag but were not certain if that was the location of the leak on all bags".The leaks were discovered during an unknown process step.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: device manufactured between february 13, 2020 to february 14, 2020.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: 500 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10554292
• MDR Text Key: 207557080
• Report Number: 1416980-2020-05813
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477220
• UDI-Public: (01)00085412477220
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: H938738
• Device Lot Number: 60226979
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1