FDA Adverse Event
Malfunction
Summary report: N
ILLUMENA-SYR-W/HF-150ML BX50
MDR report key: 1051375
·
Received May 16, 2008
Report
- Report Number
- 9610849-2008-00030
- Event Type
- Malfunction
- Date Received
- May 16, 2008
- Report Date
- October 10, 2006
- Manufacturer
- COVIDIEN
- Product Code
- DXT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER REPORT: ROOT CAUSE IDENTIFIED: ROOT CAUSE HAS NOT BEEN IDENTIFIED. CONCLUSION: THE LUER LOCK NUT, ONCE IT IS ASSEMBLED SHOULD NOT DETACH FROM THE BARREL; SYRINGE WAS DESIGNED TO KEEP THE LUER NUT IN POSITION DURING THE FUNCTIONAL TEST. CORRECTIVE ACTIONS: CAPA WAS INITIATED TO ADDRESS THE REPORTED COMPLAINT.
Description of Event or Problem · 1
CUSTOMER REPORTS VIA PHONE THAT DURING CARDIAC CATHETERIZATION LV GRAMS, THE LUER NUT IS BLOWING OFF THE TIP OF THE SYRINGE. CUSTOMER USING 4FR AND 6FR PIGTAIL CATHETERS WITH FLOW RATES OF 12ML/SEC FOR 25ML VOLUME OR 15ML/SEC FOR 40ML VOLUMES. PSI HAS NOT EXCEEDED 800PSI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ILLUMENA-SYR-W/HF-150ML BX50 | DISPOSABLE SYRINGE, EMPTY | DXT | COVIDIEN | 900101 | 6121041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |