MAUDE Adverse Event Report: WAISMED LTD NIO-I; NIO INFANT INTRAOSSEOUS ACCESS DEVICE

Medical Device Problem Codes	Difficult to Flush (1251); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Text copied from information received from customer questionnaire in handwriting on 01 november 2023: "saved to code critical in ed, in respiratory distress due to overdose of seizure medication from the new adopting parent, multiple attempts from piv"s were unsuccessful.Ed md and vat both tried nio infant io's both were able to get blood return but were not able to flush both.Since this insert goes bilaterally only with downward pressure on a lye old, we felt this product could potentially hyper extend or break the leg of the child before puncturing the bone did not flush when product was bilaterally.Finally correctly inserted it." on (b)(6) a telephone conference was had with suso and the customer.At that time the customer disclosed that the patient expired on (b)(6) 2023.

• Brand Name: NIO-I
• Common Device Name: NIO INFANT 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: 18371583
• Report Number: 9616791-2023-00005
• Device Sequence Number: 15381174
• Product Code: FMI
• UDI-Device Identifier: 07290008325066
• UDI-Public: 07290008325066
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/21/2023

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
• 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: Not provided
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 18 MO
• Patient Sex: Female