FDA Adverse Event
Malfunction
Summary report: N
ARTERIAL LINE KIT
MDR report key: 2030798
·
Received March 22, 2011
Report
- Report Number
- 1625425-2011-00030
- Event Type
- Malfunction
- Date Received
- March 22, 2011
- Date of Event
- December 6, 2010
- Report Date
- March 22, 2011
- Manufacturer
- ARGON MEDICAL DEVICES INC.
- Product Code
- GDY
- PMA / PMN Number
- K780871
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RESULTS OF INVESTIGATION WILL BE FILED IN A SUPPLEMENTAL REPORT ONCE SAMPLE HAS BEEN EVALUATED.
Description of Event or Problem · 1
DURING PROCEDURE, THE INJECTION TUBE WAS RUPTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTERIAL LINE KIT | GDY | ARGON MEDICAL DEVICES INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |