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
I am notifying you that the following complaint received by b.Braun is for info only.One complaint was written for the event description below regarding product number 412143, for "spike port adaptor leakage; spike loose" however, there are no samples, no batch number, no pictures so no scar response is required - this is for information only.This email serves as notification of the following events and no further action is required.(b)(6).When did the failure occur: before application; during preparation reason of complaint: we're having an intermittent issue occurring with the closed system spikes dislodging as the medication was infusing for a patient.Staff is aware and makes sure each spike placed is holding initially, some don't and are discarded before mix is made.However, we're having occasions when they go out of pharmacy just fine and are dislodging as nurses is hanging the medication or during the infusion.Of the two that occurred over the past week, one was infusing on patient when spike detached and the other when nursing was priming fluid from the bag for preparation to infuse.In both instances the entire contents of the medication spilled out.Drug one cost us $12,000 and drug 2 $8,552.There's a small amount of dysfunctional spikes, however due to the high cost of some of our meds one mishap becomes very costly.Does on guard reimburse back? first contact to end customer: b.Braun response expected by: customer; complaint receiver patient injury- no.(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: 24232166
• Report Number: 9611423-2026-00002
• Device Sequence Number: 18385187
• 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: 10/19/2025
• 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