MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number	1A8504
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was not available; however, a photograph of the sample and two (2) retained samples were evaluated.Visual inspection was performed on the photo sample which showed the stopper pushed into the bottle.The reported condition was verified.The cause of the condition could not be determined; however, the probable cause of the rubber insert dropping to the bottle when punctured is related to user error with an inadequate method of spiking.Visual inspection of the retained samples did not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified on the retained samples.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.
Event or Problem Description
It was reported that an evacuated container leaked immediately after an intravenous (iv) spike was inserted during the preparation of an ivig (intravenous immunoglobulin) infusion.The vial stopper of the evacuated bottle became loose and dislodged, resulting in leakage of ivig solution around the stopper area.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: NA
• Common Device Name: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CLEVELAND; 911 north davis; cleveland MS 38732
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 23550568
• Report Number: 1416980-2025-05661
• Device Sequence Number: 21253579
• Product Code: GCY
• UDI-Device Identifier: 00085412046167
• UDI-Public: (01)00085412046167(10)G174404(17)251130
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2025

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: 11/30/2025
• Device Model Number: 1A8504
• Device Catalogue Number: 1A8504
• Device Lot Number: G174404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IV SPIKE; IVIG
• Patient Sex: Unknown