INJECTOR, OPTIVANTAGE DH W/RFID 844003

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-01-14 for INJECTOR, OPTIVANTAGE DH W/RFID 844003 manufactured by Liebel-flarsheim Company.

Event Text Entries

[18565927] Pending investigation. Upon receipt of investigation, a medwatch 3500a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[18791607] Customer states via phone that during a cta of the chest/abdomen, there was an extravasation. The specific details are unk; the setting on the injector is 4ml/sec for this procedure and all ivs for this protocol are 20 gauge. The female pt, older than 60 years old was from the er. Hosp protocol for extravasations is ice and a radiologist is called to evaluate the site. The procedure was successfully completed with a new iv, and the pt was discharged without any add'l complications.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1518293-2013-00292
MDR Report Key3591146
Report Source05,06,07
Date Received2014-01-14
Date of Report2013-12-23
Date of Event2013-12-23
Date Mfgr Received2013-12-23
Device Manufacturer Date2012-11-01
Date Added to Maude2014-01-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactDAVID BENSON
Manufacturer Street2111 EAST GALBRAITH RD.
Manufacturer CityCINCINNATI OH 45237
Manufacturer CountryUS
Manufacturer Postal45237
Manufacturer Phone5139485719
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINJECTOR, OPTIVANTAGE DH W/RFID
Product CodeIZQ
Date Received2014-01-14
Model NumberOPTIVANTAGE DH W/R
Catalog Number844003
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerLIEBEL-FLARSHEIM COMPANY
Manufacturer Address2111 EAST GALBRAITH RD. CINCINNATI OH 45237 US 45237


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-01-14

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