FDA Adverse Event
Malfunction
Summary report: N
TUBE, GASTROINTESTINAL (AND ACCESS)
MDR report key: 1215472
·
Received October 24, 2008
Report
- Report Number
- 3006260740-2008-00170
- Event Type
- Malfunction
- Date Received
- October 24, 2008
- Date of Event
- September 12, 2008
- Report Date
- September 30, 2008
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- KNT
- PMA / PMN Number
- K033562
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS CONFIRMED AND WILL BE REPORTED AS MANUFACTURING RELATED. RETURNED FOR EVALUATION WAS ONE DISPOSABLE GRASPING SNARE. UPON RECEIPT THE HOOPED SNARE HAD DETACHED FROM ITS METAL LOCKING CRIMP. GROSS AND MICROSCOPIC EXAMINATIONS REVEAL AN IMPROPER CRIMP. DIMENSIONAL MEASUREMENTS FOR THE LOCKING METAL CRIMP ARE NOT WITHIN SPECIFICATIONS. A CHR LOT #HUSA0275 SHOWED NINE OTHER PRODUCT COMPLAINTS FROM THIS LOT NUMBER. REF 187519, 188387, 191631, 191638, 191645, 192149, 192640, 192665.
Description of Event or Problem · 1
THERE WAS NO ORIFICE AT THE DISTAL END OF THE SNARE OR THE HOOPED SNARE GOT DETACHED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TUBE, GASTROINTESTINAL (AND ACCESS) | KNT | C. R. BARD INC. (BASD) | HUSA0275 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |