FDA Adverse Event
Malfunction
Summary report: N
ANGIOJECT
MDR report key: 178123
·
Received July 17, 1998
Report
- Report Number
- 2024168-1998-00297
- Event Type
- Malfunction
- Date Received
- July 17, 1998
- Report Date
- June 17, 1998
- Manufacturer
- GUIDANT ACS/DVI
- Product Code
- DXT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A LEAK IN THE SYRINGE SYSTEM LED TO FILLING OF THE SYRINGE WITH AIR. THIS WAS IDENTIFIED PRIOR TO INJECTION AND REPORTEDLY, NO PT INJURY WAS ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANGIOJECT | ACCESSORY | DXT | GUIDANT ACS/DVI | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |