FDA Adverse Event
Malfunction
Summary report: N
CARDIAC CATH TRAY
MDR report key: 1182675
·
Received September 25, 2008
Report
- Report Number
- 1125782-2008-00002
- Event Type
- Malfunction
- Date Received
- September 25, 2008
- Date of Event
- August 28, 2008
- Report Date
- August 29, 2008
- Manufacturer
- MERIT MEDICAL SYSTEMS, INC.
- Product Code
- LRO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SYRINGE WITHIN THE CUSTOM KIT WAS CRACKED AT THE FIXED LUER. WHEN THE CLINICIAN PULLED BACK ON THE SYRINGE DURING A CARDIAC CATHETERIZATION PROCEDURE, BLOOD SQUIRTED OUT AND SPRAYED THE CLINICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARDIAC CATH TRAY | CATHETER, INTRAVASCULAR, DIAGNOSTIC | LRO | MERIT MEDICAL SYSTEMS, INC. | NA | V612192 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |