FDA Adverse Event
Malfunction
Summary report: N
ILLUMENA-SYR-W/HF-150ML BX50
MDR report key: 1051381
·
Received May 16, 2008
Report
- Report Number
- 9610849-2008-00017
- Event Type
- Malfunction
- Date Received
- May 16, 2008
- Date of Event
- December 1, 2006
- Manufacturer
- COVIDIEN
- Product Code
- DXT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER REPORT: ROOT CAUSE IDENTIFIED: ROOT CAUSE HAS NOT BEEN IDENTIFIED. CONCLUSIONS: THE LUER 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 THE LUER LOK NUT IS BLOWING OFF THE TIP OF THE SYRINGES UPON START OF INJECTION. SYRINGE IS CONNECTED TO MERIT MEDICAL HIGH PRESSURE CONNECTION TUBING, THAT IS CONNECTED TO MERIT MEDICAL 6FR PIGTAIL CATHETER. PROTOCOL INJECTION PARAMETERS ARE 12ML/SEC FOR 24ML VOLUME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ILLUMENA-SYR-W/HF-150ML BX50 | DISPOSABLE SYRINGE, EMPTY | DXT | COVIDIEN | 900101 | 6223331 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |