MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 5000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number	H938743
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred during the unspecified date of (b)(6) 2021.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 an unspecified quantity of 5000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags leaked where the bags were sealed in between the three ports.The leaks were discovered during setup and preparation after compounding.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to h3, h4 and h6.H10: the actual device was not available; however, four (4) companion samples were received for evaluation.Unaided visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional testing was performed on the 1 randomly selected sample which revealed a leak between the spike port tube and the spike port bond area.The reported condition was verified.The cause of the condition could not be determined; however, the most likely cause was due to inadequate or lack of cyclohexanone being applied to the spike port connector when it was inserted to the spike port tubing during manufacturing.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: 5000 ML TPN BAG
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11261234
• Report Number: 1416980-2021-00295
• Device Sequence Number: 3712030
• Product Code: LHI
• UDI-Device Identifier: 00085412477275
• UDI-Public: (01)00085412477275
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K900585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2021

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: 07/31/2021
• Device Catalogue Number: H938743
• Device Lot Number: 60140885
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1