FDA Adverse Event
Other
Summary report: N
CORFLO ULTRA NG 8FR
MDR report key: 2884770
·
Received December 10, 2012
Report
- Report Number
- 3009124963-2012-00034
- Event Type
- Other
- Date Received
- December 10, 2012
- Date of Event
- November 7, 2012
- Report Date
- December 6, 2012
- Manufacturer
- CORPAK MEDSYSTEMS
- Product Code
- KNT
- PMA / PMN Number
- K821906
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO INJURY WAS REPORTED. THE BOLUS TIP WAS NOT RETURNED WITH THE TUBE. THE RETURNED DEVICE WAS VISUALLY EXAMINED AND FOUND TO HAVE BROKEN OR TORN AT THE BOLUS (NEAR THE END OF THE FEEDING TUBE). RETENTION SAMPLES FROM SIMILAR PRODUCTS HAVE BEEN TESTED IN ORDER TO DUPLICATE A SIMILAR BREAK. MORE THAN 51LBS OF TENSILE FORCE WAS APPLIED TO THE FEEDING TUBE. IT IS UNCLEAR HOW THESE TYPES OF FORCES COULD BE APPLIED TO THE TUBE DURING CLINICAL USE.
Description of Event or Problem · 1
EVENT DESC: THE BOLUS END OF THE FEEDING TUBE SEPARATED WHILE IN THE PT. IT WAS EXCRETED WITH STOOL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORFLO ULTRA NG 8FR | FEEDING TUBE (NASOGASTRIC TUBE) | KNT | CORPAK MEDSYSTEMS | EDA 7488 | 46547 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |