MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-23 for INJ. OPTIV DH,SI W/OEM 844005 manufactured by Liebel Flarsheim.
[45755609]
Pending investigation. Upon receipt of investigation, a medwatch 3500a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[45755610]
The patient was undergoing a thoracic ct scan due to possible infection. During the procedure an extravasation occurred after injecting patient with 60 cc optiject 350 at 2ml/s. The reporter documented this case as mild in intensity. This was considered a non-serious event. The patient was treated for the extravasation with icepack, paracetamol (doliprane), control radiology and arnica prescription. The reporter reports the outcome of this event was recovered.
Patient Sequence No: 1, Text Type: D, B5
[46922911]
During ct scan an extravasation occurred after injecting patient with 60 cc optiject 350 at 2ml/s. This was considered a non-serious event. Regional service reported the injector was installed in (b)(6) 2015. Service reported that the customer never asked for service support for any issue or complaint since the installation. Service contacted customer site after this issue, and the customer did not complain about the injector, they just reported the extravasation as information only. Service performed a scheduled preventative maintenance, after this incident and confirmed the unit passed all requirements, and found all pressure and volume test values were within specifications, and the unit operated as required. No problem was found. Unit ok, remains in normal use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2016-00048 |
| MDR Report Key | 5673027 |
| Date Received | 2016-05-23 |
| Date of Report | 2016-06-07 |
| Date of Event | 2016-04-25 |
| Date Mfgr Received | 2016-04-25 |
| Device Manufacturer Date | 2012-07-31 |
| Date Added to Maude | 2016-05-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | INJ. OPTIV DH,SI W/OEM |
| Generic Name | INJ. OPTIV DH,SI W/OEM |
| Product Code | IZQ |
| Date Received | 2016-05-23 |
| Model Number | INJ. OPTIV DH,SI W/OEM |
| Catalog Number | 844005 |
| 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 ROAD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-23 |