FDA Adverse Event
Other
Summary report: N
DEROYAL MANIFOLD IN ANGIOGRAPHY PACK
MDR report key: 480193
·
Received August 13, 2003
Report
- Report Number
- 1423395-2003-00005
- Event Type
- Other
- Date Received
- August 13, 2003
- Date of Event
- June 15, 2003
- Report Date
- August 13, 2003
- Manufacturer
- MEDLINE INDUSTRIES, INC.
- Product Code
- DTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING A PROCEDURE A BUBBLE IN THE LINE WAS DETECTED BUT WAS PREVENTED FROM PROGRESSING. THE PT WAS NOT INJURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEROYAL MANIFOLD IN ANGIOGRAPHY PACK | MANIFOLD IN CONVENIENCE KIT | DTL | MEDLINE INDUSTRIES, INC. | 29599 IN DYNJ25578 | 26427 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |