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

Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Description provided by the customer: "patient was s/p cardiac arrest.Code team member arrived and was asked to place an io in the patient's leg.Patient was prepped and scrubbed in proximal left tibia.Io end cap was removed, and stylet was turned to activate the needle into position.Upon placing pressure into leg and pulling trigger, io failed to deploy fully into the bone.Cannula was removed.Second attempt was made in the proximal right tibia in similar fashion.Second io was pulled from code team bag and was a separate but similar model.Upon deploying into the bone, inner cannula was unable to be removed from the outer io cannula and thus was unable to be used appropriately.As patient had central line access at this time, attempts to place io were halted and wounds dressed with tegaderm.".

• 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: 19611823
• Report Number: 9616791-2024-00001
• Device Sequence Number: 7167618
• Product Code: FMI
• UDI-Device Identifier: 07290008325059
• UDI-Public: 07290008325059
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 06/16/2024

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): Initial
• Initial Date Received by Manufacturer: 05/25/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown