MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 4000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number	H938742
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred between december 8, 2018 ¿ september 30, 2020.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that three (3) 4000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags were leaking from unspecified locations.The leaks were discovered during setup and preparation.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H4: the lot was manufactured from september 22, 2018 - september 23, 2018.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The devices were 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: 4000 ML TPN BAG
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11386860
• Report Number: 1416980-2021-00917
• Device Sequence Number: 19874349
• Product Code: LHI
• UDI-Device Identifier: 00085412477268
• UDI-Public: (01)00085412477268
• Combination Product (Y/N): Y
• Initial Reporter Country: UY
• PMA/510(K) Number: K900585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2021

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
• Operator of Device: Other
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: H938742
• Device Lot Number: 60150440
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1