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	03/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Brief inquiry description.Incident with onguard.Detailed inquiry description.The nurse was trying to hang the bag and the tubing came out of the chemo and then the chemo spilled all over the nurse.It's apparently all bag sizes pharmacist tried different types sizes etc but the spike just seems to come out easily.

• 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: 15527738
• Report Number: 9611423-2022-00023
• Device Sequence Number: 2533046
• 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): 10/03/2022

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 Expiration Date: 11/16/2024
• Device Catalogue Number: MG412143
• Device Lot Number: UBE531
• 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: 03/14/2022
• Initial Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• 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