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

Catalog Number	412143
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
I am emailing to give some feedback on some of the issues we have been having with the on guard2 closed system transfer device bag adapter sp.Today we had the issue of an air leak in/around the adapter.The bag adapter was spiked with the tubing and the adapter was spiked into the bag as it should be.While squeezing the drip chamber on the iv tubing you could hear the air escaping the tubing from the area of the bag adapter.We ensured everything was correctly connected and even changed the tubing and the problem continued.While priming the iv tubing you could also see that there was an increase in bubbles coming into the line.This obviously could have been a serious issue if we had sent this out to the patient and air bubbles got into the line.

• 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: 22164397
• Report Number: 9611423-2025-00001
• Device Sequence Number: 17960390
• Product Code: ONB
• UDI-Device Identifier: 27290115921438
• UDI-Public: 27290115921438
• Combination Product (Y/N): N
• PMA/510(K) Number: K201142
• 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): 05/08/2025

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: UBE632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 06/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2025
• 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