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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIEBEL-FLARSHEIM INJ. OPTIV DH, W/OEM

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LIEBEL-FLARSHEIM INJ. OPTIV DH, W/OEM Back to Search Results
Model Number 844007
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Exposure to Body Fluids (1745)
Event Date 01/31/2018
Event Type  malfunction  
Event Description
After saline injection the catheter is removed and the customer is stating residual pressure is present and saline and bodily fluids are released on 2 separate occurrences the bodily fluid and saline has then come into contact with the eye of the staff. Residual pressure build up; using y tubing; catheter size nexiva catheters 22 and 20 gauge; manufacturer of syringes: guerbet ultraject saline and optiray 320 125 ml prefilled contrast. Follow up information received on 28 february 2018 from the reporter, procedure being performed was abdominal/pelvic ct. Incident occurred when removing the tubing from the iv. As corrective treatment, the staff member received an eye flush at an eye wash station and had a blood draw for a baseline study. The patient was also requested to come in and have this done at a later date, but to date she has not done this. Nothing was found for the staff member's blood work. A potential user error is not excluded while disconnecting (tubing not clamped, abnormal disconnection method, or other issues) but an "injector contribution" to the event cannot be excluded.
 
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Brand NameINJ. OPTIV DH, W/OEM
Type of DeviceINJ. OPTIV DH, W/OEM
Manufacturer (Section D)
LIEBEL-FLARSHEIM
2111 e. galbraith rd
cincinnati OH 45237
Manufacturer Contact
fred reckelhoff
2111 e. galbraith rd
cincinnati, OH 45237
MDR Report Key7303422
MDR Text Key102078242
Report Number1518293-2018-00005
Device Sequence Number1
Product Code IZQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Radiologic Technologist
Type of Report Initial
Report Date 01/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/28/2018
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? No
Event Location No Information
Date Manufacturer Received01/31/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/31/2011
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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