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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL ARROW EZ IO NEEDLE SET; NEEDLE, HYPODERMIC, SINGLE LUMEN
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TELEFLEX MEDICAL ARROW EZ IO NEEDLE SET; NEEDLE, HYPODERMIC, SINGLE LUMEN Back to Search Results
Device Problems Detachment of Device or Device Component (2907); Improper Flow or Infusion (2954)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/30/2019
Event Type  malfunction  
Event Description
45mm 15ga arrow ez io needle inserted by ed staff.Nurse states fluids infusing without difficulty but would not give blood return.Femoral line in process of being inserted left groin at same time and successful.Team opted to remove io needle once femoral line established.During removal process of io, housing came off but needle remained in patient.Rt leg vice grips required to assist in needle removal following counterclockwise motion no lot number information due to room cleaned and trash emptied prior to io removal issue.
 
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Brand Name
ARROW EZ IO NEEDLE SET
Type of Device
NEEDLE, HYPODERMIC, SINGLE LUMEN
Manufacturer (Section D)
TELEFLEX MEDICAL
3015 carrington mill blvd.
morrisville NC 27560
MDR Report Key8926110
MDR Text Key155372173
Report Number8926110
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/02/2019
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
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/02/2019
Event Location Hospital
Date Report to Manufacturer08/23/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age24455 DA
Patient Weight90
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