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 Patient Involvement (2645)
Date of Event	10/28/2020
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 twenty-six (26) units of 4000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags were leaking coming at the port.The leaks were discovered during setup and preparation.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to d10, h3, h4, and h6.H10: only three (3) actual samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional testing was performed with tap water which revealed a leak between the spike port cap tube and the spike port bonding area of all 3 samples.The reported condition was verified for the returned samples.The cause of the condition was not determined; however, the most likely cause was due to inadequate or lack of cyclohexanone applied during the manufacturing process.The remaining twenty-three (23) samples were not received for evaluation; therefore, a device analysis could not be completed for those samples.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: 10880215
• Report Number: 1416980-2020-07287
• Device Sequence Number: 3803291
• Product Code: LHI
• UDI-Device Identifier: 00085412477268
• UDI-Public: (01)00085412477268
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K900585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

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: 60148501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1