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 2014-01-14 for INJECTOR, OPTIVANTAGE DH W/RFID 844003 manufactured by Liebel-flarsheim Company.
[21311586]
Customer states via phone that during a cta of the chest/abdomen there was an extravasation. The specific details are unk; the setting on the injector is 4ml/sec for this procedure and all ivs for this protocol are 20 gauge. The male pt, older than 60 years old was from the er. Hosp protocol for extravasations is ice and a radiologist is called to evaluate the site. The procedure was successfully completed with a new iv, and the pt was discharged without any add'l complications.
Patient Sequence No: 1, Text Type: D, B5
[21661948]
Pending investigation. Upon receipt of investigation, a medwatch 3500a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2013-00290 |
| MDR Report Key | 3591165 |
| Report Source | 05,06,07 |
| Date Received | 2014-01-14 |
| Date of Report | 2013-12-23 |
| Date of Event | 2013-12-23 |
| Date Mfgr Received | 2013-12-23 |
| Device Manufacturer Date | 2012-11-01 |
| Date Added to Maude | 2014-01-27 |
| 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 |
| 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 |
| Product Code | IZQ |
| Date Received | 2014-01-14 |
| Model Number | OPTIVANTAGE DH W/R |
| Catalog Number | 844003 |
| 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 COMPANY |
| Manufacturer Address | 2111 EAST GALBRAITH RD. CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-01-14 |