FDA Adverse Event
Malfunction
Summary report: N
3CC-E CMB 25X 5/8 A
MDR report key: 1232072
·
Received November 7, 2008
Report
- Report Number
- 1017768-2008-00028
- Event Type
- Malfunction
- Date Received
- November 7, 2008
- Date of Event
- October 8, 2008
- Report Date
- November 5, 2008
- Manufacturer
- COVIDIEN
- Product Code
- FMI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN IN 2008 THAT A CUSTOMER HAD AN ISSUE WITH A NEEDLE AND SYRINGE WHILE DRAWING UP MEDICATION. THE CUSTOMER REPORTS MEDICAL ASSISTANT ATTEMPTED TO DRAW UP FLU VACCINE, AND THE NEEDLE FELL OFF THE NEEDLE HUB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3CC-E CMB 25X 5/8 A | NEEDLE AND SYRINGE | FMI | COVIDIEN | 1180325058 | 501084 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |