SITUATE

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCT: G0804-12P02C-1, GAUZE; XRAY; RFD; 8X4; 12-PLY; STRL; LF; (LOT#241102AT); G0804-12P02C-1, GAUZE; XRAY; RFD; 8X4; 12-PLY; STRL; LF; (LOT#241102AT); G0804-12P02C-1, GAUZE; XRAY; RFD; 8X4; 12-PLY; STRL; LF; (LOT#241102AT). 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

ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE ITEM MANAGER PROCEEDED TO OPEN ONE OF THE ITEMS IN THE CASE, THE GAUZE WAS FRAYING OFF. WHEN THREE MORE RAYTEC PACKAGES WERE OPENED, ALL OF THEM LOOKED ALIKE (FRAYING OFF). 4/4 OPENED. THERE WAS NO PATIENT INVOLVEMENT.