FDA Adverse Event
Malfunction
Summary report: N
BARD PLATINUM CLASS FLAT WIRE STONE BASKET
MDR report key: 3915695
·
Received June 12, 2014
Report
- Report Number
- 1018233-2014-00153
- Event Type
- Malfunction
- Date Received
- June 12, 2014
- Date of Event
- April 17, 2014
- Report Date
- May 21, 2014
- Manufacturer
- C.R. BARD, INC. (COVINGTON)
- Product Code
- FFL
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THE TIP BECAME DISCONNECTED DURING THE PROCEDURE. THE DEVICE WAS RETRIEVED FROM THE PT. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 346796 | BARD PLATINUM CLASS FLAT WIRE STONE BASKET | FFL | C.R. BARD, INC. (COVINGTON) | NA | BMWGM021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |