FDA Adverse Event
Malfunction
Summary report: N
3CC SAF. SYR 20X1-1/2
MDR report key: 803915
·
Received January 4, 2007
Report
- Report Number
- 1650158-2007-00001
- Event Type
- Malfunction
- Date Received
- January 4, 2007
- Report Date
- December 19, 2006
- Manufacturer
- TYCO HEALTHCARE/KENDALL
- Product Code
- MEG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- UNKNOWN
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 TYCO HEALTHCARE/KENDALL ON 12/19/2006 THAT A CUSTOMER HAD A PROBLEM WITH A SAFETY NEEDLE. THE CUSTOMER STATED THAT THE NEEDLE DETACHED FROM THE HUB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3CC SAF. SYR 20X1-1/2 | SAFETY NEEDLE | MEG | TYCO HEALTHCARE/KENDALL | 8881533056 | 601801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |