FDA Adverse Event
Malfunction
Summary report: N
30G DENTAL NDL
MDR report key: 1423049
·
Received March 30, 2009
Report
- Report Number
- 1017768-2009-00085
- Event Type
- Malfunction
- Date Received
- March 30, 2009
- Report Date
- March 12, 2009
- Manufacturer
- COVIDIEN
- Product Code
- DZM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: 03/27/2009. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN IN 2009, THAT A CUSTOMER HAD AN ISSUE WITH A DENTAL NEEDLE. THE CUSTOMER REPORTS NEEDLE APPEAR TO BE SHORT. AN EVALUATION OF THE SAMPLES RECEIVED AT THE PLANT REVEALED THAT THE CANNULA WAS SLIDING INTO THE HUB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 30G DENTAL NDL | DENTAL NEEDLE | DZM | COVIDIEN | 8881401072 | 813050 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |