REBAR
Report
- Report Number
- 9612501-2025-01296
- Event Type
- Malfunction
- Date Received
- May 16, 2025
- Date of Event
- May 12, 2025
- Report Date
- May 23, 2025
- Manufacturer
- MEDTRONIC DOMINICANA
- Product Code
- KRA
- PMA / PMN Number
- K093750
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
IT WAS REPORTED THAT PRIOR TO THE START OF TREATMENT, THE PHYSICIAN OPENED THE BLISTER OF THE MICRO CATHETER 105-5081-153 REBAR IR AND OBSERVED A DEFECT AT THE TIP, LEADING TO THE CATHETER BEING DISCARDED. THE CATHETER WAS FOUND TO BE CRUSHED, KINKED, OR DAMAGED, WITH THE DAMAGE LOCATED DISTALLY. ADDITIONALLY, THERE WAS A SEPARATION OR BREAK IN THE CATHETER, WHICH WAS IDENTIFIED OUT OF THE PACKAGE OR DURING PREPARATION. THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE. THERE WAS NO PATIENT INVOLVED.
ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1182882 | REBAR | CATHETER, CONTINUOUS FLUSH | KRA | MEDTRONIC DOMINICANA | 105-5081-153 | 0227534826 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |