FDA Adverse Event
Malfunction
Summary report: N
1 QT N/S CONTAINER RED 100
MDR report key: 988766
·
Received January 30, 2008
Report
- Report Number
- 1424643-2008-00002
- Event Type
- Malfunction
- Date Received
- January 30, 2008
- Report Date
- January 28, 2008
- Manufacturer
- TYCO/KENDALL HEALTHCARE
- Product Code
- MMK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, 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 TYCO/KENDALL HEALTHCARE THAT A CUSTOMER HAD AN ISSUE WITH A SHARPS CONTAINER. THE CUSTOMER REPORTS "AN INSULIN NEEDLE WAS DISCARDED INTO THE SHARPS CONTAINER AND THE NEEDLE POKED THROUGH THE CONTAINER AND AN EMPLOYEE RECEIVED A CONTAMINATED NEEDLE STICK."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1 QT N/S CONTAINER RED 100 | SHARPS CONTAINER | MMK | TYCO/KENDALL HEALTHCARE | 8900SA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |