FDA Adverse Event
Other
Summary report: N
UNKNOWN SAFETY NEEDLE
MDR report key: 3190153
·
Received June 18, 2013
Report
- Report Number
- 1915484-2013-00016
- Event Type
- Other
- Date Received
- June 18, 2013
- Date of Event
- May 6, 2013
- Report Date
- May 20, 2013
- Manufacturer
- COVIDIEN
- Product Code
- FMF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2013. 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) 2013 THAT A CUSTOMER HAD AN ISSUE WITH AN INSULIN SAFETY SYRINGE. THE CUSTOMER REPORTED THAT THEY HEARD A CLICK WHEN ACTIVATING THE SAFETY FEATURE, THEN FELT A STICK THROUGH THEIR GLOVE. THE CUSTOMER STATED THEY EXAMINED THE DEVICE AND THE SAFETY SHIELD HAD NOT FULLY COVERED THE NEEDLE. NORMAL HOSPITAL PROTOCOL WAS FOLLOWED FOR A NEEDLE STICK INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 277222 | UNKNOWN SAFETY NEEDLE | INSULIN SAFETY SYRINGE | FMF | COVIDIEN | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other |