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 2014-01-08 for INJ. OPTIV DH, W/OEM OPTIVANTAGE DH 844007 manufactured by Liebel Flarsheim.
[17842896]
Customer reports via phone that (b)(6) female was having a ct of the chest/abd/pelvis with contrast. I. V. Access was a 20 gauge angiocath in the left antecubital. Optiray 320 100 ml prefilled syringe loaded into the injector system. Injection protocol of 2 ml/sec for 100 ml at 300 psi. When the injection and scan were completed, the staff notice approximately 5 - 7 ml of air having been injected. Patient did not show any symptoms or have any complaints of pain or discomfort. No treatment was required. Customer did report the injector low pressure line was connected to the patient i. V. Tubing. They suspect the normal saline had run dry and could account for approximately 5 - 7 ml of air in the tubing which was not noticed prior to contrast injection.
Patient Sequence No: 1, Text Type: D, B5
[18231414]
Pending investigation. Upon receipt of investigation, a medwatch 3500a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2013-00289 |
| MDR Report Key | 3587272 |
| Report Source | 05,06,07 |
| Date Received | 2014-01-08 |
| Date of Report | 2013-12-18 |
| Date of Event | 2013-12-18 |
| Date Mfgr Received | 2013-12-18 |
| Device Manufacturer Date | 2013-07-01 |
| Date Added to Maude | 2014-01-23 |
| 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 RD. |
| 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 | INJ. OPTIV DH, W/OEM |
| Product Code | IZQ |
| Date Received | 2014-01-08 |
| Model Number | OPTIVANTAGE DH |
| Catalog Number | 844007 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL FLARSHEIM |
| Manufacturer Address | 2111 EAST GALBRAITH RD. ROAD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-01-08 |