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)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a black dot/ particle was observed inside a supor syringe filter.This occurred before use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: h6 (update codes), h11.H11: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed on the photo sample which showed a black embedded particulate on the filter housing.The black embedded particulate is consistent with char.The embedded char is a by-product of injection moulding, where charred material from the resin heating and feed process can manifest as embedded particulate material.This is a cosmetic condition only and has no impact on product functionality.The reported condition was verified.The cause was most likely related to manufacturing.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 ; 2242702068
• MDR Report Key: 22664635
• Report Number: 1416980-2025-03967
• Device Sequence Number: 11691417
• Product Code: FMF
• UDI-Device Identifier: 05413765482670
• UDI-Public: (01)05413765482670(10)2024-GR00034818(17)270430
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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 Model Number: H93821050
• Device Catalogue Number: H93821050
• Device Lot Number: 2024-GR00034818
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 02/03/2026
• 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
• Patient Sex: Unknown