MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-02-20 for LIEBEL-FLARSHEIM INJECTOR 800005 UNK manufactured by Mallinckrodt.
[20686268]
During ct scan, it was noticed that patient had air in the heart. It was seen in the rt. Axillary and subclavian vein as well as the superior vena cava, rt. Atrium, rt. Ventricle and main pulmonary trunk. Pt. Needed to be intubated and placed on ventilator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 820545 |
| MDR Report Key | 820545 |
| Date Received | 2007-02-20 |
| Date of Report | 2007-02-16 |
| Date of Event | 2007-02-06 |
| Date Facility Aware | 2007-02-06 |
| Report Date | 2007-02-16 |
| Date Reported to FDA | 2007-02-19 |
| Date Reported to Mfgr | 2007-02-19 |
| Date Added to Maude | 2007-02-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIEBEL-FLARSHEIM INJECTOR |
| Generic Name | CONTRAST MEDIA INJECTOR |
| Product Code | MJS |
| Date Received | 2007-02-20 |
| Model Number | 800005 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 808008 |
| Manufacturer | MALLINCKRODT |
| Manufacturer Address | 2111 EAST GALBRAITH ROAD CINCINNATI OH * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2007-02-20 |