MAUDE Adverse Event Report: SIMPLIVIA HEALTHCARE LTD. CHEMFORT; ONGUARD2 BAG ADAPTOR SP

Catalog Number	412143
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We are notifying you that we have received one complaint (b)(4) from our customer regarding your product.Spike loose or falls out.Material- 412143.Batch- ube657.No sample.(b)(4).Customer (b)(6)), epic care.When did the failure occur: during preparation.Reason of complaint: having issues with ref: (b)(4) onguard bag adaptor, where the spike is slipping off the bag and causing chemo spills and waste.Response expected by: customer; complaint receiver.Patient injury- no.Attached information- (b)(4) registration form customer complaint.

• Brand Name: CHEMFORT
• Common Device Name: ONGUARD2 BAG ADAPTOR SP
• Manufacturer (Section D): SIMPLIVIA HEALTHCARE LTD.; eli horovitz 1; north industrial zone; kiryat shmona, hazafon 11018 01; IS 1101801
• Manufacturer (Section G): SIMPLIVIA HEALTHCARE LTD; eli horovitz 1; kiryat shmona, 11018 01; IS 1101801
• Manufacturer Contact: shay shaham ; eli horovitz 1; north industrial zone; kiryat shmona, hatzafon 11018-01 ; IS 1101801
• MDR Report Key: 24232318
• Report Number: 9611423-2026-00003
• Device Sequence Number: 18446675
• Product Code: ONB
• UDI-Device Identifier: 37290115921435
• UDI-Public: 37290115921435
• Combination Product (Y/N): N
• PMA/510(K) Number: K192866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2025

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
• Device Catalogue Number: 412143
• Device Lot Number: UBE657
• 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: 10/22/2025
• Initial Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2025
• 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