EZ-IO POWER DRIVER 9058

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-23 for EZ-IO POWER DRIVER 9058 manufactured by Teleflex Medical.

Event Text Entries

[188653736] (b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10


[188653737] The report states: we have a bad drill that was put into service not that long ago. It was being used on a live patient, but the customer did not have any other information and did not have the driver on hand for sn/lot. When asked if the green light was turning on and he was not sure. When asked if the user was aware that they could manually insert the needle he was not sure of that either. Additional information: the customer sent me the driver sn: (b)(4). It looks like the manufactured year was 2011 which would make sense that this driver is dated. But he did say the green light is on and that it was tried and failed on 2 different patients.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011137372-2020-00093
MDR Report Key9864929
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-23
Date of Report2020-03-20
Date of Event2020-03-20
Date Mfgr Received2020-03-20
Date Added to Maude2020-03-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactEFFIE JEFFERSON
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194332672
Manufacturer G1TELEFLEX MEDICAL
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal Code27560
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEZ-IO POWER DRIVER
Generic NameNEEDLE, HYPODERMIC, SINGLE LU
Product CodeFMI
Date Received2020-03-23
Catalog Number9058
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressATHLONE


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-23

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