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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a 5000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag leaked from additive port.There were no signs of physical distress to the product or shipping materials.This was identified during filling of the bag.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The device evaluation was completed.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed which revealed a leak between the spike port tube and the spike port bonding 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 applied to the spike port cap tube when it was inserted to the spike port during the manufacturing process causing an incorrect bonding.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: 11466997
• Report Number: 1416980-2021-01259
• Device Sequence Number: 4624918
• Product Code: LHI
• UDI-Device Identifier: 00085412477275
• UDI-Public: (01)00085412477275
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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): 04/14/2021

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: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: H938743
• Device Lot Number: 60139369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1