MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SUPOR; SYRINGE, PISTON

Model Number	H93821050
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During evaluation of a returned supor syringe filter, a dark foreign matter was observed inside the device.No additional information is available.
Additional Manufacturer Narrative
The actual device and a photograph of the sample was provided for evaluation.Visual inspection was performed on all the samples which showed a dark spot of foreign matter inside the filter.The reported condition was verified.The cause was most likely inherent to contamination during the manufacturing and or packaging 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: SUPOR
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): PALL CORPORATION; st. columb major ind est; st columb major (cornwall) TR9 6 TT; UK TR9 6TT
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24537237
• Report Number: 1416980-2026-00873
• Device Sequence Number: 18398757
• Product Code: FMF
• UDI-Device Identifier: 05413765482670
• UDI-Public: (01)05413765482670(10)2023-GR00024632(17)260731
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K941589
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

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: 07/31/2026
• Device Model Number: H93821050
• Device Catalogue Number: H93821050
• Device Lot Number: 2023-GR00024632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: NA.
• Patient Sex: Unknown