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	03/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Brief inquiry description: new onguard spike adaptor 412143 falling off from bag and tip of device broken detailed inquiry description: while spiking a baxter bag the tip of the spike adaptor 412143 broke, also they found it very sharp and short and the baxter bag got perforated and it leaked.While using the spike adaptor 412143 with (b)(6) pab 500ml bag the spike adaptor felt off at the bedside and the oncology drug was all over the nurse and patient.Was medical intervention necessary- no.Was therapy incomplete, incorrect or interrupted- no.Injury- no.

• 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: 15621947
• Report Number: 9611423-2022-00025
• Device Sequence Number: 6470598
• 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): 10/05/2022

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: 03/29/2022
• Initial Report FDA Received Date: 10/18/2022
• 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