MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ-IO POWER DRIVER; NEEDLE, HYPODERMIC, SINGLE LU

Model Number	IPN915667
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.Associated report: 3011137372-2023-00074.
Event or Problem Description
Reported issue: the same driver failed during 2 different resuscitations on 2 different patients: after the driver failed initially failed on one patient, it was tested on an artificial bone and worked perfectly.Thus, it was put back into use, but then failed again on another patient.In both cases, a replacement driver was available and io access was achieved with the replacement driver.There was no delay in treatment.Both patients were not harmed by the defect.
Event or Problem Description
Reported issue: the same driver failed during 2 different resuscitations on 2 different patients: after the driver failed initially failed on one patient, it was tested on an artificial bone and worked perfectly.Thus, it was put back into use, but then failed again on another patient.In both cases, a replacement driver was available and io access was achieved with the replacement driver.There was no delay in treatment.Both patients were not harmed by the defect.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Associated report: 3011137372-2023-00074.

• Brand Name: EZ-IO POWER DRIVER
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16622475
• Report Number: 3011137372-2023-00075
• Device Sequence Number: 7325175
• Product Code: FMI
• UDI-Device Identifier: 10816000013813
• UDI-Public: 10816000013813
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K180395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2023

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: IPN915667
• Device Catalogue Number: 9058
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 04/19/2023
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Age: 70 YR
• Patient Sex: Unknown