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)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a 4000 ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was leaking from the top seam.The leak was discovered prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H4: the lot was manufactured from november 09, 2020 - november 10, 2020.H10: the device was received for evaluation.Unaided visual inspection was performed which did not identify any abnormalities that could have contributed to the reported condition.Additional magnified inspection was performed which observed a small tear across the front side seam under the top hanger hole area.Functional testing was performed which revealed a leak on the affected area.The reported condition was verified.The cause of the condition could not be determined.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: 4000 ML TPN BAG
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12475243
• Report Number: 1416980-2021-05729
• Device Sequence Number: 3655668
• Product Code: LHI
• UDI-Device Identifier: 00085412477268
• UDI-Public: (01)00085412477268
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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: 10/31/2023
• Device Catalogue Number: H938742
• Device Lot Number: 60268332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1