SITUATE
Received Oct 20, 2025 · Event occurred Sep 20, 2025
Report 1717344-2025-01355 · MDR key 23341596
Device
Product problems
- False Negative Result
- False Negative Result
Patient
NA · Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
D10 CONCOMITANT PRODUCT: 01-0046, 01-0046 BLAIR PORT WAND X (LOT#: UNKNOWN). 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.
Description of Event or Problem
IT WAS REPORTED THAT DURING PROCEDURE, THE CONSOLE REPORTED A NEGATIVE (CLEAR) SCAN, BUT A COTTON PACK WAS RETAINED IN THE PATIENT. TWO SEPARATE SCANS WERE COMPLETED, ALONG WITH TWO MANUAL COUNTS AND ALL GIVING CLEAR SCANS AND CORRECT COUNTS. THE PATIENT HAD TO BE RETURNED TO THE OPERATING ROOM FOR COTTON REMOVAL. THE HOSPITALIZATION OF THE PATIENT WAS EXTENDED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, G3. 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.
Description of Event or Problem
IT WAS REPORTED THAT, DURING PROCEDURE, THE CONSOLE REPORTED A NEGATIVE (CLEAR) SCAN JUST PRIOR TO CLOSURE AND AFTER CLOSURE, BUT A COTTON PACK WAS RETAINED IN THE PATIENT. TWO SEPARATE SCANS WERE COMPLETED AND BOTH SCANS PERFORMED WITH THE SAME CONSOLE AND BLAIR-PORT WAND COMBO, ALONG WITH TWO MANUAL COUNTS AND ALL GIVING CLEAR SCANS AND CORRECT COUNTS. THE PATIENT HAD TO BE RETURNED TO THE OPERATING ROOM FOR COTTON REMOVAL. THE HOSPITALIZATION OF THE PATIENT WAS EXTENDED.