MAUDE Adverse Event Report: WAISMED LTD NIO ADULT; INTRAOSSEOUS ACCESS DEVICE

Model Number	NIO A
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint description from customer on (b)(6) 2023."vat nurse opened package, unlocked device by twisting top, squeezed down and the needle did not deploy.Second nurse stepped in and attempted to deploy needle and got a negative response.They opened another unit, followed the same steps, and successfully deployed needle into patient.There was a one-to-two-minute delay between start and deployment because of this incident.Both nurses have been trained on the device and have successfully used it in the past".

• Brand Name: NIO ADULT
• Common Device Name: INTRAOSSEOUS ACCESS DEVICE
• Manufacturer (Section D): WAISMED LTD; 10 amal st; afek industrial park; rosh ha'yin, 48092 34; IS 4809234
• Manufacturer (Section G): WAISMED LTD; 10 amal st; afek industrial park; rosh ha'yin, 48092 34; IS 4809234
• Manufacturer Contact: giovani munoz ; 10 amal st; afek industrial park; rosh ha'yin, 48092-34 ; IS 4809234
• MDR Report Key: 17955292
• Report Number: 9616791-2023-00004
• Device Sequence Number: 15233751
• Product Code: FMI
• UDI-Device Identifier: 07290008325059
• UDI-Public: 07290008325059
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142086
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/15/2023

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: 11/12/2025
• Device Model Number: NIO A
• Device Catalogue Number: 105000603
• Device Lot Number: 2040021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (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 Sex: Unknown