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

Model Number	NIO-A
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer has been contacted several times in an attempt to obtain additional details concerning the device involved in the reported event.Unfortunately, we have not received any clarification or further information regarding the event or returning of the device itself.We will continue trying to get extra details and a follow up report will be done in case of new information is received.
Event or Problem Description
Complaint descrption from customer on october 15, 2024: "we recently had an nio adult device malfunction during a code event.We stock these in our code carts and when my team member attempted to insert the device, following the ifu, it deployed, with delay, and actually fell apart.Follows is the communication i received from my colleague: i went to place an nio during a code and it was very difficult to deploy the nio.I am comfortable placing the nio and using the nio device.The device i used was from the crash cart and there are no extras in the crash cart when something like this occurs.Here was the sequence: i had unlocked it, uncapped it, was stabilizing it and did the squeeze and finally, after what seemed like an eternity in a bad situation, it did deploy but at the same time, the entire nio apparatus exploded.Literally.I don't know what to say.I did save it for you if you want to take a look, but that is seriously what happened.I came back to the office after i was organized and grabbed another nio just to see if it was me and nope.It deployed easy just like it should.No issues and no explosion.No harm was done to the patient other than a delay in vascular access.I have the actual device, in pieces, in a bag to send for inspection.I would like to report this for the record.".

• Brand Name: NIO ADULT
• Common Device Name: INTRAOSSEOUS ACCESS DEVICE FOR ADULTS
• 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: 20648712
• Report Number: 9616791-2024-00002
• Device Sequence Number: 8865773
• Product Code: FMI
• UDI-Device Identifier: 07290008325059
• UDI-Public: 07290008325059
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): 10/11/2024

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
• Device Model Number: NIO-A
• Device Catalogue Number: 105000603
• Device Lot Number: 2340036
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 11/10/2024
• Date Device Manufactured: 03/04/2023
• 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
• Patient Sex: Unknown