FDA Adverse Event
Malfunction
Summary report: N
STANDARD RIGID TIP SUCTION WAND
MDR report key: 2746545
·
Received September 13, 2012
Report
- Report Number
- 2028837-2012-00002
- Event Type
- Malfunction
- Date Received
- September 13, 2012
- Date of Event
- August 3, 2012
- Report Date
- September 13, 2012
- Manufacturer
- CALIFORNIA MEDICAL LABORATORIES, INC.
- Product Code
- DTS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL LOT # S112462; EXP DATE: 11/01/2014. DEVICE MFR DATE: 11/2011. DEVICE EVAL SUMMARY: THE SUBJECT DEVICE (8 EA.) WERE RETURNED TO OUR FACILITY ON (B)(4) 2012. THE DEVICES WERE DECONTAMINATED AND SUBSEQUENTLY AN INVESTIGATION WAS INITIATED TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT. THIS INVESTIGATION IS STILL UNDERWAY AT THIS TIME.
Description of Event or Problem · 1
THE TIPS OF THE SUCTION WANDS ARE LOOSE AND COMING OFF DURING OPERATION OR SOME ARE LOOSE INSIDE THE PACKET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STANDARD RIGID TIP SUCTION WAND | STANDARD RIGID TIP SUCTION WAND | DTS | CALIFORNIA MEDICAL LABORATORIES, INC. | SU-12202 | S111480, S112462 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |