ESOFLIP

Description of Event or Problem

IT WAS REPORTED THAT A CATHETER WAS FOUND TO HAVE AN UNIDENTIFIABLE MATTER DESCRIBED AS ¿SOMETHING FLOATING¿ IN THE PREFILLED SOLUTION INSIDE THE CATHETER, AND CONTAMINATION WAS ALSO OBSERVED INSIDE THE PACKAGING WITHOUT TOUCHING THE DEVICE. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND BIOLOGICAL CONTAMINATION HAS BEEN IDENTIFIED IN PRIOR SYRINGES CONTAINING PARTICULATE CONTAMINATION. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. INSPECTION OF THE RETURNED SYRINGE NOTED BLACK PARTICULATE MATTER SUSPENDED IN THE SALINE SOLUTION. BIOLOGICAL CONTAMINATION HAS BEEN IDENTIFIED IN PRIOR SYRINGES CONTAINING PARTICULATE CONTAMINATION. IT WAS REPORTED THAT THERE WAS A FOREIGN OBJECT FOUND IN THE PACKAGE OR PRODUCT. THE REPORTED ISSUE WAS CONFIRMED. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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.