FDA Adverse Event
Malfunction
Summary report: N
SOFTCLIX® LANCET DEVICE
MDR report key: 1781527
·
Received August 3, 2010
Report
- Report Number
- 1823260-2010-04579
- Event Type
- Malfunction
- Date Received
- August 3, 2010
- Date of Event
- July 28, 2010
- Report Date
- August 20, 2010
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- FMK
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
CUSTOMER REPORTS LANCET PROTRUDES BEYOND THE END CAP OF THE SOFTCLIX DEVICE. NO ACCIDENTAL NEEDLE STICK OCCURRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
Description of Event or Problem · 1
ATTEMPTS TO ADVANCE THE GUIDE WIRE INTO THE VEIN WITH MULTIPLE STENOTIC AREAS WAS MET WITH RESISTANCE. UPON RETRACTING THE GUIDE WIRE, THE TIP FRACTURED IMMEDIATELY BELOW THE SKIN SURFACE REQUIRING A CUT-DOWN PROCEDURE TO REMOVE THE RETAINED DEVICE FRAGMENT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFTCLIX® LANCET DEVICE | LANCET DEVICE | FMK | ROCHE DIAGNOSTICS | NA | BAV068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |