ESOFLIP

Description of Event or Problem

IT WAS REPORTED THAT THE CATHETER CONTAINED FLOATING BITS IN THE FLUID. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. MEDTRONIC WAS NOTIFIED OF THE FOLLOWING REPORTED CONDITION: IT WAS REPORTED THAT THE CATHETER CONTAINED FLOATING BITS IN THE FLUID. INSPECTION OF THE RETURNED SYRINGE NOTED THAT THERE WAS A FOREIGN OBJECT SUSPENDED IN THE SALINE. A VISUAL INSPECTION OF THE IMAGES NOTED: CONTAMINATED SYRINGES WITH AN UNIDENTIFIED FLOATING SUBSTANCE. A SAMPLE WAS SENT FOR TESTING WHICH IDENTIFIED THE FLOATING SUBSTANCE AS A BIOLOGICAL CONTAMINANT. THE MOST LIKELY CAUSE WAS DETERMINED TO BE MANUFACTURING RELATED. 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.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, G3, H3 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. A VISUAL INSPECTION OF THE IMAGES NOTED CONTAMINATED SYRINGES WITH AN UNIDENTIFIED FLOATING SUBSTANCE. INSPECTION OF THE RETURNED SYRINGE NOTED THAT THERE WAS A FOREIGN OBJECT SUSPENDED IN THE SALINE. THE SAMPLE WAS SENT FOR TESTING WHICH IDENTIFIED THE FLOATING SUBSTANCE AS A BIOLOGICAL CONTAMINANT. IT WAS REPORTED THAT THE EIGHT CATHETERS CONTAINED FLOATING BITS IN THE FLUID. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE WAS DETERMINED TO BE MANUFACTURING RELATED. INTERNAL PROCESS IMPROVEMENTS HAVE BEEN INITIATED TO MITIGATE THIS ISSUE. 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 THE EIGHT CATHETERS CONTAINED FLOATING BITS IN THE FLUID. THERE WAS NO PATIENT INVOLVEMENT.