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	12/23/2025
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 port adaptor leakage; spike loose.Material-412166.Batch-ubr522.No sample.(b)(4).Customer (b)(4), (b)(6) outpatient pharmacy.When did the failure occur: during therapy.Reason of complaint: iv spike, (b)(4), came out when assessing secure connection on abraxane, med spilled on pump and floor.Cleaned spill and notified pharmacy that a new bag was needed.Noted.Based on dispense preparation images, appears that onguard2 bag adaptor was fully pushed into bag port though angles make it difficult to confirm with certainty.Response expected by: customer; complaint receiver.Attached information: others.Products related to complaint.Manufacturer of disposable: simplivia.Article / batch: 412166/ubr522.Manufacturer of drug: american regent, inc.Ndc 0517-4300-01.Article / batch: albumin bound paclitaxel150mg, exp 07/27/lot 90038f0021.Others: icu medical.Article / batch: 100ml empty bag/list no.7951-23.Patient injury-no.Attached information- (b)(4) registration form customer complaint picture, no sample.

• 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: 24232549
• Report Number: 9611423-2026-00005
• Device Sequence Number: 15758199
• 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: UBR522
• 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: 10/12/2025
• Initial Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2025
• 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