MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2015-05-20 for INJECTOR, OPTIVANTAGE DH W/RFID 844003 manufactured by Liebel Flarsheim.
[5856623]
Customer reports (b)(6) female having a chest/abd/pelvis ct had 13ml of optiray 320 infiltrate into the left ante cubital vein. The patient had a 24 gauge iv access device connected to a heplock valve, connected to the low pressure tubing and prefilled optiray 320, 100ml prefilled syringe. Injection protocol of 1. 0ml/sec for 75ml volume. The patient was treated with massage, ice paks and extremity elevation for about 30 minutes. Infiltration resolved and patient is fine. No additional details are known.
Patient Sequence No: 1, Text Type: D, B5
[13397479]
Pending investigation. Upon receipt of investigation, a medwatch 3500a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[26262014]
Customer has determined only one technologist had this problem with the injector, the other technologists did not experience the issue. The technologist that had the problem has not had any recent issues, so at this time, they do not wish to have a field service engineer (fse) evaluate the system. They believe the injector to be fully functional. Unit remains in service. Complaint database history search shows no other similar issues with this unit. No further investigation needed at this time. Qa will continue to monitor and trend for similar issues. Customer reports no problems.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2015-00034 |
| MDR Report Key | 4784495 |
| Report Source | 05,06,07 |
| Date Received | 2015-05-20 |
| Date of Report | 2015-06-05 |
| Date of Event | 2015-04-24 |
| Date Mfgr Received | 2015-04-24 |
| Device Manufacturer Date | 2012-04-30 |
| Date Added to Maude | 2015-05-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RADIOLOGIC TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID BENSON |
| Manufacturer Street | 2111 EAST GALBRAITH ROAD |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Manufacturer Phone | 5139485719 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INJECTOR, OPTIVANTAGE DH W/RFID |
| Generic Name | OPTIVANTAGE DH W/RFID |
| Product Code | IZQ |
| Date Received | 2015-05-20 |
| Model Number | OPTIVANTAGE DH W/RFID |
| Catalog Number | 844003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL FLARSHEIM |
| Manufacturer Address | 2111 EAST GALBRAITH ROAD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-05-20 |