FDA Adverse Event
Malfunction
Summary report: N
LIFEGUARD
MDR report key: 1820285
·
Received July 1, 2010
Report
- Report Number
- 1820285
- Event Type
- Malfunction
- Date Received
- July 1, 2010
- Date of Event
- June 22, 2010
- Report Date
- July 1, 2010
- Manufacturer
- CHURCHILL MEDICAL SYSTEMS INC
- Product Code
- FMI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VA, US
Narratives
Description of Event or Problem · 1
SAFETY COVER OF LIFEGUARD NON-CORING SAFETY INFUSION SET (LNSIS)NEEDLE FAILED TO REMAIN ENGAGED AFTER USE AND RESULTED IN HEALTH CARE PROVIDER NEEDLE STICK. FURTHER EVALUATION OF FUNCTIONALITY OF ALL SIMILAR DEVICES REVEALS THAT IT IS EASILY RETRACTABLE- MAY SLIP AND EXPOSE A USED NEEDLE PRIOR TO SAFE DISPOSAL. WE ARE CONCERNED THAT THIS IS A PROBLEM OF DESIGN OF THE LNSIS NEEDLE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================SAFETY GUARD DISENGAGES -- NOT LOCKING IN PLACE OVER NEEDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEGUARD | NON-CORING SAFETY INFUSION SET | FMI | CHURCHILL MEDICAL SYSTEMS INC | * | 1003006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | NO OTHER THERAPIES |