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 2014-04-22 for INJECTOR, OPTIVANTAGE DH W/RFID 844003 manufactured by Liebel-flarsheim.
[21719659]
Customer reports via phone, they were doing a ct chest on an approx (b)(6) male when the patient reported his arm felt warm after the injection. Injection protocol was 2. 3ml/sec for 70ml volume of contrast (optiray 320, 100ml prefilled syringe) and 35ml of saline. Staff noted swelling around the injection site of the right antecub. The radiologist was called to evaluate the site, indicating it was probably the saline, since the contrast bolus was noted on the scan images. Staff applied a cold compress and monitored for 30 minutes. Swelling resolved, and the patient said he felt fine. Staff released patient, asking them to report to the er immediately if any changes were noted. They have not heard from the patient. No reported injury.
Patient Sequence No: 1, Text Type: D, B5
[21917232]
The customer reported a extravasation occurred during an injection. The field service engineer (fse) arrived on site after the extravasation occured and verified proper operation of the injector per service checklist (b)(4). No issues were found by the fse. The fse noted the recorded pressure in the injection history was 50psi.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2014-00044 |
| MDR Report Key | 3778103 |
| Report Source | 05,06,07 |
| Date Received | 2014-04-22 |
| Date of Report | 2014-03-31 |
| Date of Event | 2014-03-31 |
| Date Mfgr Received | 2014-03-31 |
| Device Manufacturer Date | 2012-06-01 |
| Date Added to Maude | 2014-04-30 |
| 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 | INJECTOR, OPTIVANTAGE DH W/RFID |
| Generic Name | IZQ |
| Product Code | IZQ |
| Date Received | 2014-04-22 |
| Model Number | INJECTOR, OPTIVANT |
| Catalog Number | 844003 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL-FLARSHEIM |
| Manufacturer Address | 2111 EAST GALBRAITH RD. CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-04-22 |