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Model Number 844007
Device Problems Filling Problem (1233); Defective Device (2588)
Patient Problems Respiratory Distress (2045); Complaint, Ill-Defined (2331); No Code Available (3191)
Event Date 08/20/2018
Event Type  malfunction  
Event Description
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.
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Type of DeviceINJ. OPTIV DH, W/OEM
Manufacturer (Section D)
2111 e galbraith road
cincinnati OH 45237
Manufacturer Contact
fred reckelhoff
2111 e galbraith road
cincinnati, OH 45237
MDR Report Key7885010
MDR Text Key121461408
Report Number1518293-2018-00033
Device Sequence Number1
Product Code IZQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number844007
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage