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 Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a 2000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag leaked from left side seam above the numbers.This was discovered during setup and preparation.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Correction made to f10/h6: component codes: g04113 added (previously not submitted).H4: the lot was manufactured between october 12, 2020 - october 13, 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 discarded; therefore, a device analysis could not be completed.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: 11349008
• MDR Text Key: 232569112
• Report Number: 1416980-2021-00741
• 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
• Type of Report: Initial,Followup
• Report Date: 02/19/2021

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: 09/30/2023
• Device Catalogue Number: H938740
• Device Lot Number: 60262617
• Was Device Available for Evaluation?: No
• 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