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

Catalog Number	MG412143
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	05/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A product complaint has been issue for the defective item.Item 412143 7 cs.Description: item leaking.Customer open 1cs and used the 1bx ( 2bx/cs ) but 1bx was leaking.They stopped using the entire order ( 7cs ).

• Brand Name: ONGUARD2
• Common Device Name: ONGUARD2 BAG ADAPTOR SP
• Manufacturer (Section D): SIMPLIVIA HEALTHCARE LTD.; eli horovitz 1,; north industrial zone; kiryat shmona, 11018 01; IS 1101801
• Manufacturer (Section G): SIMPLIVIA HEALTHCARE LTD.; eli horovitz 1; north industrial zone; kiryat shmona, 11018 01; IS 1101801
• Manufacturer Contact: shay shaham ; eli horovitz 1; north industrial zone; kiryat shmona, 11018-01 ; IS 1101801
• MDR Report Key: 15549370
• Report Number: 9611423-2022-00036
• Device Sequence Number: 19304208
• Product Code: ONB
• UDI-Device Identifier: 37290115921435
• UDI-Public: 37290115921435
• 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: Pharmacist
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/06/2022

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 Catalogue Number: MG412143
• 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: 05/18/2022
• Initial Report FDA Received Date: 10/06/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1057-2022
• Patient Sequence Number: 1
• Patient Sex: Unknown