MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ IO 25MM NEEDLE SET + STABILIZER; NEEDLE, HYPODERMIC, SINGLE LU

Catalog Number	9001P-VC-005
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Ischemia (1942); Reduced Blood Flow (4598)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported by clinical staff at the facility that: "post trauma patient, coded in icu, multiple failed cvc attempts, io placed by rn in tibia with physicians present, rosc achieved, io used for meds and blood administration for multiple hours, patient later developed compartment syndrome and went to or for fasciotomy, but then underwent complications post op and is deceased now.The facility has stated that the issue was user-error as the io was reported to the rep to have been placed mid-shaft on the tibia." it was also reported that "multiple issues compiled throughout his stay and that he was noncompliant during his stay." the patient's death was at least 6 hours post the incident but the facility did not disclose the exact timeline.
Additional Manufacturer Narrative
(b)(4).The complaint cannot be confirmed.Complaint verification testing could not be performed as no sample was returned for analysis.The ifu provided with this kit states, "insertion sites: adults (= 22 years old): proximal humerus, proximal tibia, distal tibia.Pediatrics (= 21 years old): proximal humerus, proximal tibia, distal tibia, distal femur".Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported by clinical staff at the facility that: "post trauma patient, coded in icu, multiple failed cvc attempts, io placed by rn in tibia with physicians present, rosc achieved, io used for meds and blood administration for multiple hours, patient later developed compartment syndrome and went to or for fasciotomy, but then underwent complications post op and is deceased now.The facility has stated that the issue was user-error as the io was reported to the rep to have been placed mid-shaft on the tibia." it was also reported that "multiple issues compiled throughout his stay and that he was noncompliant during his stay." the patient's death was at least 6 hours post the incident but the facility did not disclose the exact timeline.

• Brand Name: EZ IO 25MM NEEDLE SET + STABILIZER
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LU
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19269831
• Report Number: 3011137372-2024-00063
• Device Sequence Number: 7034415
• Product Code: FMI
• UDI-Device Identifier: 00816000011881
• UDI-Public: 00816000011881
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 9001P-VC-005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 06/03/2024
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Race: Native Hawaiian Or Other Pacific Islander