CARDINAL HEALTH

Description of Event or Problem

IT WAS REPORTED THAT POST-OPERATIVELY, A LAPAROTOMY SPONGE WAS RETAINED IN THE PATIENT FOLLOWING A SURGICAL PROCEDURE, NECESSITATING A SECOND SURGERY TO RETRIEVE THE SPONGE. THE RETAINED SPONGE RESULTED IN EXTENDED PATIENT'S HOSPITALIZATION BY 3-4 DAYS. AN X-RAY WAS TAKEN TO ASSIST IN LOCATING THE RETAINED SPONGE. PATIENT WAS INITIALLY TAKEN TO INTENSIVE CARE UNIT BUT HAD TO RETURN DUE TO COMPLICATIONS. THE SPONGE WAS FULLY RETRIEVED DURING THE SECOND SURGERY. IT WAS NOTED THAT THE SPONGE COUNT WAS CORRECT, AND MACHINE READ A CORRECT COUNT AT THE END OF THE INITIAL PROCEDURE BUT DID NOT DETECT A SPONGE WAS IN THE PATIENT.

Additional Manufacturer Narrative

THE PRODUCTION PROCESS WAS INVESTIGATED. DURING THE PRODUCTION, THERE WERE FOUR STEPS FOR CONFIRMING THE PRODUCT QUANTITY. THE CUSTOMER DID NOT PROVIDED THE DEFECTIVE BATCH AND SAMPLES. THE CUSTOMER DID NOT NOTICE ANY MISCOUNT EITHER. THEREFORE, THE AFFECTED DEVICE COULD NOT BE EVALUATED TO CONFIRM THE REPORTED FAILURE. AS SUCH, A ROOT CAUSE COULD NOT BE DETERMINED.