BARDIA® FOLEY CATHETER INSERTION TRAY
Report
- Report Number
- 1018233-2018-03206
- Event Type
- Malfunction
- Date Received
- August 1, 2018
- Report Date
- August 16, 2018
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- OHR
- UDI-DI
- 00801741018282
- PMA / PMN Number
- PREAMENDMENT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.
UPON FURTHER REVIEW, BARD MEDICAL HAS DETERMINED THAT THIS MDR WAS INITIALLY REPORTED IN ERROR AS THIS EVENT IS NOT REPORTABLE.
IT WAS REPORTED THAT THE BZK WIPES WERE MISSING FROM THE FOLEY INSERTION TRAY.
IT WAS REPORTED THAT THE BZK WIPES WERE MISSING FROM THE FOLEY INSERTION TRAY.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE WAS NOT RETURNED.
IT WAS REPORTED THAT THE BZK WIPES WERE MISSING FROM THE FOLEY INSERTION TRAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 580010 | BARDIA® FOLEY CATHETER INSERTION TRAY | FOLEY TRAY | OHR | C.R. BARD, INC. (COVINGTON) -1018233 | 802010 | NGCR4484 | 00801741018282 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |