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

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.

• Brand Name: INJ. OPTIV DH, W/OEM
• Type of Device: INJ. 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 Key: 7303422
• MDR Text Key: 102078242
• Report Number: 1518293-2018-00005
• Device Sequence Number: 1
• Product Code: IZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063503
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 844007
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2018
• Date Device Manufactured: 01/31/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 38 YR