MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2H5660
Medical Device Problem Codes	Backflow (1064); Fluid/Blood Leak (1250); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G1: 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 blood backed up into a non-dehp extension set which was also leaking air into the filter and leaking fluid from an unspecified location.This event was observed during patient use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
D4: expiration date: update to n/a.E1: initial reporter phone no.: (b)(6).H11: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was 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: SOLUTION ADMINISTRATION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h11; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19960281
• Report Number: 1416980-2024-04189
• Device Sequence Number: 7065031
• Product Code: FPA
• UDI-Device Identifier: 00085412065328
• UDI-Public: (01)00085412065328(10)R20F19029
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K153158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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: 06/19/2025
• Device Model Number: 2H5660
• Device Catalogue Number: 2H5660
• Device Lot Number: R20F19029
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2020
• 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