FDA Adverse Event
Malfunction
Summary report: N
ILLUMENA-SYR-W/HF-150ML (LINDEN LUER)
MDR report key: 1160571
·
Received September 11, 2008
Report
- Report Number
- 9610849-2008-00070
- Event Type
- Malfunction
- Date Received
- September 11, 2008
- Date of Event
- August 6, 2008
- Report Date
- August 13, 2008
- Manufacturer
- COVIDIEN
- Product Code
- DXT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ROOT CAUSE IDENTIFIED: NO SAMPLES WERE RECEIVED FOR EVALUATION. CONCLUSIONS: IN PREVIOUS COMPLAINTS, IT WAS FOUND THAT SYRINGE BARREL (B) (4) MOLD WAS NOT WITHIN SPECIFICATION. THEREFORE, THE MOLD WAS REPAIRED ON 01/11/2008. THIS LOT NUMBER WAS MANUFACTURED BEFORE THE MOLD REPAIR.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT A (B) (6) MALE WAS UNDERGOING A CARDIAC CATH DIAGNOSTIC PROCEDURE TO VISUALIZE THE LEFT VENTRICLE WHEN THE 4FR PIGTAIL CATHETER DETACHED FROM THE SYRINGE. CUSTOMER REPORTED THAT THE PROTOCOL FOR THE INJECTION WAS 30ML OF CONTRAST AT A FLOW RATE OF 15ML/SEC WITH A PSI OF 1000.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ILLUMENA-SYR-W/HF-150ML (LINDEN LUER) | DISPOSABLE SYRINGE | DXT | COVIDIEN | 900103 | 7222114 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |