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

Model Number 844007

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 03/15/2018

Event Type  malfunction  

Event Description

The contrast was injected, the psi "was fine", "there was no contrast enhancement inside the images"."the contrast was injected into her tissue and not into her veins" they were using opti-ray contrast.They stated the customer had some pain put a cold pack in the area.

• 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
• MDR Report Key: 7421640
• MDR Text Key: 105419765
• Report Number: 1518293-2018-00010
• 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
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 844007
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2018
• Date Device Manufactured: 08/31/2016
• Type of Device Usage: N
• Patient Sequence Number: 1