MAUDE Adverse Event Report: STERIS CORPORATION ALARIS, SMARTSITE; LOW SORBING EXTENSION SET

Model Number	20350E
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Isomedix operations inc.(steris ast) received medwatch report#: mw5185572 related to a bd smartsite unit.The product identified in the medwatch report is neither manufactured by steris ast, nor is steris ast the applicant holding the premarket approval (pma).The medwatch report was forwarded to the device manufacturer on april 22, 2026, for investigation and evaluation of potential medical device reporting under 21 cfr 803.Carefusion (bd) confirmed via email that an internal investigation was initiated under#: (b)(4).Complaint (b)(4) was initiated by the temecula, ca facility.The investigation included a batch review of load ala-1162-19612 that was processed on november 15, 2025, for the identified product and lot#: 25105525.No failures were identified during the sterilization process.
Event or Problem Description
The ast temecula, ca facility received a medwatch report#: mw5185572, indicating the bd smartsite low sorbing extension set 0.2 micron filter was clogging/malfunctioning during use.

• Brand Name: ALARIS, SMARTSITE
• Common Device Name: LOW SORBING EXTENSION SET
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley rd; mentor 44060
• Manufacturer (Section G): STERIS CORPORATION; 5960 heisley rd; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4402597401
• MDR Report Key: 25191148
• Report Number: 1527821-2026-00005
• Device Sequence Number: 10427426
• Product Code: FPA
• UDI-Device Identifier: 07613203012256
• UDI-Public: (01)07613203012256(17)281017(10)25105525
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

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: Health Professional
• Device Model Number: 20350E
• Device Catalogue Number: 20350E
• Device Lot Number: (10)25105525
• 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: 04/16/2026
• Initial Report FDA Received Date: 05/15/2026
• 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