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

Catalog Number	2R1145
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device manufacturer address 1: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that three (3) non-dehp iv fat emulsion administration sets had damaged lines.This was further described as: two (2) of the lines were cut in two and separated near the filter and one (1) had a split in the middle length wise.This was identified before use; prior to infusion and noticed while still in the packaging.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The devices were not received for evaluation; therefore, a device analysis could not be completed.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 ; 2242702068
• MDR Report Key: 15085962
• Report Number: 1416980-2022-03785
• Device Sequence Number: 4119368
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022

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: 06/12/2023
• Device Catalogue Number: 2R1145
• Device Lot Number: R21F11058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 08/25/2022
• Date Device Manufactured: 06/12/2021
• 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