FDA Adverse Event
Malfunction
Summary report: N
TRAY BONANNO CATHETER S/SU
MDR report key: 11388571
·
Received February 26, 2021
Report
- Report Number
- 2618282-2021-00015
- Event Type
- Malfunction
- Date Received
- February 26, 2021
- Date of Event
- February 3, 2021
- Report Date
- February 22, 2021
- Manufacturer
- BD CARIBE LTD.
- Product Code
- FEZ
- UDI-DI
- 00382904082895
- PMA / PMN Number
- PREAMENDMENT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT TRAY BONANNO CATHETER S/SU CATHETER BROKE APART. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REASON FOR COMPLAINT: THE METAL INSIDE (NEEDLE) OF THE CATHETER WAS VERY STIFF TO RE INSERT BACK INTO THE CATHETER PRIOR TO BEING INSERTED. THEN WHEN THE NEEDLE PUSHED BACK INTO CATHETER THE END 3 OR 4 CMS OF THE CATHETER CAME OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 285868 | TRAY BONANNO CATHETER S/SU | SUPRAPUBIC UROLOGICAL CATHETER AND ACCESSORIES | FEZ | BD CARIBE LTD. | 408289 | 0013214 | 00382904082895 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |