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	10/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We are notifying you that we have received one complaint (b)(4), cc 400739359 from our customer regarding your product.Description: cc 400739359, spike loose or falls out, 412143 on guard spike port adaptor, batch: unknown.Customer: (b)(6) (b)(6) system on (b)(6) 2025.Good morning, the on guard 2 cstd bag adaptor 412143 fits very loosely in all bbraun bags.It is particularly loose in the 500ml bag.Today, the spike fell out of the bag creating a significant spill of the antineoplastic.It appears that my colleagues at the other ahs sites are having similar issues.I need to take action immediately.Consequently, i appreciate a prompt response.Rph, ms, pharmd, ccp pharmacy director centra state medical center freehold, nj 07728 on (b)(6) 2025: customer complaint advocate seems to have been escalated - had a meeting yesterday.They noticed this when they first switched to b.Braun back in september - were using baxter and facile.Noticed that it fit very loosely in our bags - in non-b, braun bags is a tight fit.Some minor leaks yesterday a major leak - luckily contained in the hood.Chemo agent fell on staff (operation pharmacist).And in the past on a nurse - this was at overlook part of atlantic health system.The pharmacist - young female- childbearing went hysterical on him went off occupational health assessed to calm down and sent home for the rest of the day.Fell all over her luckily, she had he gowns and gloves on her but concerned about fumes -does not sequester everything.And two other incidents cannot recall where they were.Was using on guard 2 (ends in 143) this seems to be the issue recommendation to use the legacy product which has an extended tube, this is on guard 1 not on guard 2 which is supposed to be an improvement.Issues escalated to upper leadership.His staff reported that they have more issues with the 500ml bags.At overlook it was a liter bag - with testing it seems to not be exclusive to any particular to size bag.Believes a b.Braun representative share that the issue was found in the manufacturing process, that there was too much silicone in the tip of the on guard 2.

• 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: 24232203
• Report Number: 9611423-2026-00004
• Device Sequence Number: 13308945
• 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
• 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
• 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