MAUDE Adverse Event Report: SIMPLIVIA HEALTHCARE LTD ONGUARD2; SYRINGE ADAPTOR

Catalog Number	412163
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The 412163 came loose causing an open connection.The patient bled on himself while family was present.No injury.

• Brand Name: ONGUARD2
• Common Device Name: SYRINGE ADAPTOR
• Manufacturer (Section D): SIMPLIVIA HEALTHCARE LTD; north industrial zone; kyriat shmona, 11018 01; IS 1101801
• Manufacturer (Section G): SIMPLIVIA HEALTHCARE LTD; north industrial zone; kyriat shmona, 11018 01; IS 1101801
• Manufacturer Contact: shay shaham ; north industrial zone; kyriat shmona, 11018-01 ; IS 1101801
• MDR Report Key: 16662556
• Report Number: 9611423-2023-00001
• Device Sequence Number: 15107341
• Product Code: ONB
• UDI-Device Identifier: 37290115921633
• UDI-Public: 37290115921633
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Catalogue Number: 412163
• Device Lot Number: UBN554
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 14 YR
• Patient Sex: Unknown