MAUDE Adverse Event Report: WAISMED LTD. NIO- ADULT; NIO-ADULT

Model Number	NIO-A
Health Effect - Clinical Code	Swelling (2091)
Date of Event	07/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the complainant event description, and the fact that bone marrow was drawn, waismed can assume that the needle was placed in the marrow cavity following properly device activation.The device has not been returned for investigation.Devices from the same lot number from the archive were used for evaluation.The investigation is ongoing.Waismed will continue to monitor and trend related events.Because field in this report is mandatory, malfunction was marked, but based on the above, the malfunction was not established, and waismed assumption is that the device was activated properly.
Event or Problem Description
It was reported that the nio deployed in the left tibia of the patient.After flushing, it was reported that bone marrow was present and needle placement in the marrow cavity was confirmed.Several minutes after deployment, patient's leg appeared swollen in comparison to his right leg.The patient became responsive to treatments after access via different io needle was placed.
Event or Problem Description
It was reported that the nio deployed in the left tibia of the patient.After flushing, it was reported that bone marrow was present and needle placement in the marrow cavity was confirmed.Several minutes after deployment, patient's leg appeared swollen in comparison to his right leg.The patient became responsive to treatments after access via different io needle was placed.
Additional Manufacturer Narrative
Based on the complainant event description, and the fact that bone marrow was drawn, waismed can assume that the needle was placed in the marrow cavity following properly device activation.The device has not been returned for investigation.Devices from the same lot number from the archive were used for evaluation.The investigation is ongoing.Waismed will continue to monitor and trend related events.Because field in this report is mandatory, malfunction was marked, but based on the above, the malfunction was not established, and waismde assumption is that the device was activated properly.

• Brand Name: NIO- ADULT
• Common Device Name: NIO-ADULT
• Manufacturer (Section D): WAISMED LTD.; 10 amal street; afek industrial park; rosh haayin, hamerkaz 48092 34; IS 4809234
• MDR Report Key: 7917513
• Report Number: 9616791-2018-00001
• Device Sequence Number: 11214237
• Product Code: FMI
• UDI-Device Identifier: 07290008325059
• UDI-Public: (01)07290008325059(10)1730055(17)220917
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/17/2022
• Device Model Number: NIO-A
• Device Catalogue Number: 105000601
• Device Lot Number: 1730055
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 100