FDA Adverse Event Malfunction Summary report: N

NIO ADULT

MDR report key: 19611823 · Received June 26, 2024

Report

Report Number
9616791-2024-00001
Event Type
Malfunction
Date Received
June 26, 2024
Date of Event
April 3, 2024
Report Date
June 16, 2024
Manufacturer
WAISMED LTD
Product Code
FMI
UDI-DI
07290008325059
PMA / PMN Number
K142086
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
IS
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

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."

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
674265 NIO ADULT INTRAOSSEOUS ACCESS DEVICE FMI WAISMED LTD 07290008325059

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown