FDA Adverse Event
Malfunction
Summary report: N
ILLUMENA-SYR-W/HF-150 ML BX50
MDR report key: 1051401
·
Received May 16, 2008
Report
- Report Number
- 9610849-2008-00045
- Event Type
- Malfunction
- Date Received
- May 16, 2008
- Report Date
- March 8, 2007
- Manufacturer
- COVIDIEN
- Product Code
- DXT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ROOT CAUSE IDENTIFIED: ROOT CAUSE HAS NOT BEEN IDENTIFIED. CONCLUSIONS: 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 (B) (4) WAS INITIATED TO ADDRESS THE REPORTED COMPLAINT.
Description of Event or Problem · 1
CUSTOMER REPORTS VIA PHONE THAT THEY HAVE EXPERIENCE 5 - 6 SYRINGES WHERE THE LUER LOCK NUT DETACHES FROM THE SYRINGE DURING USE. SYRINGE IS CONNECTED TO MERIT MEDICAL HIGH PRESSURE TUBING, WITH CONNECTION TO A CORDIS 6FR PIGTAIL. INJECTOR PROTOCOL WAS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ILLUMENA-SYR-W/HF-150 ML BX50 | DISPOSABLE SYRINGE, EMPTY | DXT | COVIDIEN | 900101 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |