FDA Adverse Event
Injury
Summary report: N
KENDALL ARGYLE
MDR report key: 1211155
·
Received October 24, 2008
Report
- Report Number
- 1211155
- Event Type
- Injury
- Date Received
- October 24, 2008
- Date of Event
- September 12, 2008
- Report Date
- October 23, 2008
- Manufacturer
- COVIDIEN
- Product Code
- JOL
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
WHILE THE NURSE WAS SUCTIONING THE PT, THE PT BROKE OFF THE TIP OF THE YANKAUER SUCTION TUBE. THE GASTROENTEROLOGIST WAS CALLED AND HE RETRIEVED THE PIECE THAT MEASURED 4.5 X 1 X 0.8 CM. THE PT TOLERATED THE PROCEDURE WITH NO FURTHER SEQUELAE. TIP SENT TO PATHOLOGY TO ASSESS WHETHER PROD DEFECT, INDETERMINATE. AFTER REVIEW, IT WAS DECIDED TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KENDALL ARGYLE | YANKAUER SUCTION TUBE | JOL | COVIDIEN | 8888505016 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Life Threatening |