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 scar-(b)(4) cc-(b)(4) from our customer regarding your product.Spike port adaptor leakage; spike loose; material- 412143; batch- ube654; no sample; (b)(4) customer (b)(6), epic care; when did the failure occur: during preparation.Reason of complaint: having issues with ref: 412143 ongard bag adaptor, where the spike is slipping off the bag and causing chemo spills and waste.Response expected by: customer; complaint receiver.Recorded via- email.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: 24243858
• Report Number: 9611423-2026-00007
• Device Sequence Number: 15540259
• 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): 03/02/2025

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: UBE654
• 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: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2025
• 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