BARD® ELLIK EVACUATOR

Description of Event or Problem

IT WAS REPORTED THAT CUSTOMER HAD SOME ISSUES WITH THE ELLIK BLADDER EVACUATOR BALL WHICH WAS NOT FIXING PROPERLY TO THE PLASTIC HOSE. THE DEVICE (BATCH NO. #NGJY0730) WAS USED WHILE THE PATIENT WAS ASLEEP ON THE OPERATION TABLE. ANOTHER DEVICE (BATCH NO. #NGJV5134) SOURCED FROM ANOTHER HOSPITAL AND TESTED IN THEATER WITH NO PATIENT.

Additional Manufacturer Narrative

THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. THIS OCCURRENCE DOES NOT INTRODUCE A NEW HAZARD OR HARM. IT REPRESENTS A KNOWN FAILURE MODE THAT HAS BEEN ASSESSED IN THE PRODUCT RISK MANAGEMENT FILE IN ACCORDANCE WITH APPLICABLE REGULATORY STANDARDS AND INTERNAL PROCEDURES. THE ASSOCIATED RISKS CONTINUE TO BE MONITORED AS PART OF ONGOING POST-MARKET ACTIVITIES IN COMPLIANCE WITH BOTH REGULATORY REQUIREMENTS AND LOCAL PROCEDURES. THE LABELING IS FOUND TO BE ADEQUATE AS THE INSTRUCTIONS FOR USE STATE: DO NOT USE IF PACKAGE IS DAMAGED. FILL WITH SOLUTION. DISPLACE ALL AIR BEFORE USING. NOTE: FOR USE WITH RESECTOSCOPE SHEATH MANUFACTURED BY R. WOLF AND K. STORZ. A SEPARATE ADAPTER IS ENCLOSED FOR USE WITH RESECTOSCOPE SHEATH MANUFACTURED BY ACMI. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. CORRECTION: D. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THAT CUSTOMER HAD SOME ISSUES WITH THE ELLIK BLADDER EVACUATOR BALL WHICH WAS NOT FIXING PROPERLY TO THE PLASTIC HOSE. THE DEVICE (BATCH NO. #NGJY0730) WAS USED WHILE THE PATIENT WAS ASLEEP ON THE OPERATION TABLE. ANOTHER DEVICE (BATCH NO. #NGJV5134) SOURCED FROM ANOTHER HOSPITAL AND TESTED IN THEATER WITH NO PATIENT.