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

Model Number	IPN915667
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Reported event: needles not connecting to driver.
Event or Problem Description
Reported event: needles not connecting to driver.
Additional Manufacturer Narrative
(b)(4).Ez-io driver 9058 was returned for evaluation.Upon receipt, the driver was visually inspected.The magnet in the driver shaft was missing from the device.No other physical damage or defects were observed with the driver shaft or device.The complaint is confirmed.The driver was opened to test and record operating characteristics.An attempt was made to read the eeprom data to analyze usage.The eeprom data was parsed and revealed a charge count of 1,499,425 and a cycle count (trigger pulls) of 178.The cycle count of 178 is significant as it substantiates driver usage with considerations to bone density, average insertion time, storage, and frequency of testing.This data reveals evidence of use prior to the reported defect.Further inspection of the internal shaft was performed and there was visual evidence of glue residue.According to r & d, this indicates that the magnet was placed and properly assembled to the shaft during the manufacturing process.The manufacturing device history file was reviewed.No recorded results of manufacturing issues or anomalies were reported.It could not be determined exactly when or how the magnet became loose and fell from the device.Therefore, the root cause of this issue is unknown at this time.

• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16265313
• Report Number: 3011137372-2023-00010
• Device Sequence Number: 6007002
• Product Code: FMI
• UDI-Device Identifier: 10816000013813
• UDI-Public: 10816000013813
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Unknown