FDA Adverse Event
Malfunction
Summary report: N
25X5/8 MAGELLAN SAFETY NEEDLE
MDR report key: 2072597
·
Received April 23, 2011
Report
- Report Number
- 1017768-2011-00014
- Event Type
- Malfunction
- Date Received
- April 23, 2011
- Report Date
- April 11, 2011
- Manufacturer
- COVIDIEN
- Product Code
- FMI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A SAFETY NEEDLE. THE CUSTOMER REPORTS, THE SAFETY DEVICE DID NOT LOCK AFTER THE SAFETY GLIDE WAS ENGAGED AND RESULTED IN A NEEDLE STICK. THE EMPLOYEE REC'D CARE ACCORDING TO THE HOSPITAL PROTOCOL THROUGH EMPLOYEE OCCUPATIONAL HEALTH SERVICES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 25X5/8 MAGELLAN SAFETY NEEDLE | SAFETY NEEDLE | FMI | COVIDIEN | 8881850558 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |