INJ. OPTIV DH, W/OEM 844007

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-18 for INJ. OPTIV DH, W/OEM 844007 manufactured by Liebel-flarsheim.

Event Text Entries

[121461408] Initial notification on (b)(6) 2018, reporter states that intermittently, when putting on syringes user can not see if air is present, potential air injection, patient attached and felt ill after injection. Report receiver spoke with ct technologist, and she said they have difficulty making sure that all of the air is purged out of the syringe and y-tubing. She asked if lf has a clear, non-opaque, syringe available. Report receiver explained that we do not. She was not asserting that the injector malfunctioned and caused air to be injected, rather she said that the fact that the 200 ml syringes are opaque and not clear contributed to a possible air injection. They have decided not to use the injector until an fse comes and looks at the system. They would also like applications to give them a call. In regards to patient injury, reporter states that tech hooked up contrast and saline syringes, hit auto fill, went to scanner, the injector said it was filled. Tech cannot see if its filled. Tech hit purge. Looked like contrast came in, saline came in. Looked as if it was working, hooked up to patient. Patient got warm assumed she got contrast, but then air came through because patient go a lot of air? Patient started coughing and said felt ill. Injector said there was 100 cc's in there was air on the scan. Everything seemed as if it was working ok, but tech states clearly was not. Follow-up with reporter on (b)(6) 2018, reporter states that the contrast and saline used during this procedure was omnipaque 300 and an unnamed non-guerbet 0. 9% sodium chloride.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1518293-2018-00033
MDR Report Key7885010
Date Received2018-09-18
Date of Report2018-08-20
Date of Event2018-08-20
Date Mfgr Received2018-08-20
Device Manufacturer Date2018-02-28
Date Added to Maude2018-09-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactFRED RECKELHOFF
Manufacturer Street2111 E GALBRAITH ROAD
Manufacturer CityCINCINNATI OH 45237
Manufacturer CountryUS
Manufacturer Postal45237
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameINJ. OPTIV DH, W/OEM
Generic NameINJ. OPTIV DH, W/OEM
Product CodeIZQ
Date Received2018-09-18
Model Number844007
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerLIEBEL-FLARSHEIM
Manufacturer Address2111 E GALBRAITH ROAD CINCINNATI OH 45237 US 45237


Patients

Patient NumberTreatmentOutcomeDate
10 2018-09-18

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