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

Catalog Number	H938743
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported 2 5000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags leaked.The event was further described as the "middle port fell out and all drug components leaked out onto" the air flow hood.The event occurred during product preparation; which is prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Device manufacture date: august 06, 2018 - august 07, 2018.The actual devices were not available; however, a photograph of one sample was provided for evaluation the photograph was visually inspected and observed the spike port tube with the cap detached from the spike port.The reported condition was verified.The cause of the condition was not determined; however, the most likely cause was due to inadequate or lack of cyclohexanone applied to the spike port 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.
Additional Manufacturer Narrative
Correction: b4/f8: date of this report in mdr follow up #1 is being corrected from blank to 05/12/2021.

• 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: 11668066
• Report Number: 1416980-2021-02125
• Device Sequence Number: 16898005
• Product Code: LHI
• UDI-Device Identifier: 00085412477275
• UDI-Public: (01)00085412477275
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 07/29/2021

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: 60139360
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 04/30/2021; 07/01/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 05/12/2021; 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1