MAUDE Adverse Event Report: WAISMED LTD. NIO ADULT; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	NIO-A
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
When first received by the manufacturer, reportability assessment was conducted and it was determined that it didn't require to be reported.When additional information was received on may 3rd 2022, reportability assessment was conducted again and it was determined that the this is an event that should be reported.
Event or Problem Description
The following information was provided by the user on (b)(6) 2022: describe the event or problem: io (intraosseous needle) was placed to deliver lifesaving medications.There was no catheter with the needle.This caused a delay with patient getting medications.What was the original intended procedure? to deliver pressors and rsi medications.What problem did the user have (check all that apply): device malfunction - that is, the device did not do what it was supposed to do.

• Brand Name: NIO ADULT
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): WAISMED LTD.; 10 amal st.; afek industrial park; rosh haayin, 48092 34; IS 4809234
• Manufacturer (Section G): WAISMED LTD.; 10 amal st.; afek industrial park; rosh haayin, 48092 34; IS 4809234
• Manufacturer Contact: shifra hoch ; 10 amal st.; afek industrial park; rosh haayin, 48092-34 ; IS 4809234
• MDR Report Key: 14565969
• Report Number: 9616791-2022-00001
• Device Sequence Number: 14897713
• Product Code: FMI
• UDI-Device Identifier: 07290008325059
• UDI-Public: 07290008325059
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2022

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: 06/01/2022
• Device Model Number: NIO-A
• Device Catalogue Number: NIO-A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2022
• Initial Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2020
• 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
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Race: Black Or African American