MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION IV FAT EMULSION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2R1145
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a non-dehp iv fat emulsion administration set leaked from the drip chamber.This was identified before use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H10: two (2) devices were received for evaluation.A visual inspection was performed using the naked eye and no defects were observed.Functional tests including pressure test and clear passage under water tests were performed and the results were not satisfactory; a leak between the assembly of the tubing into the drip chamber was observed on both samples.A dimensional test was performed, at the tubing and the results were according to specification.The reported condition was verified on both samples.The cause of the condition was determined to be either an improper manual assembly, an incorrect amount of solvent or an incorrect assembly method during the manufacturing process.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: IV FAT EMULSION ADMINISTRATION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16488943
• Report Number: 1416980-2023-00854
• Device Sequence Number: 5659911
• Product Code: FPA
• UDI-Device Identifier: 00085412565620
• UDI-Public: (01)00085412565620
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K172544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2023

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: 07/02/2023
• Device Catalogue Number: 2R1145
• Device Lot Number: R21G01065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2023
• Supplement Date Received by Manufacturer: 04/02/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown