CARDINAL HEALTH

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED AS NO LOT INFORMATION WAS PROVIDED WITHIN THE COMPLAINT. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. DURING PRODUCTION, INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. THERE WERE NO SAMPLES RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED DEVICE COULD NOT BE EVALUATED TO CONFIRM THE REPORTED FAILURE. AS SUCH, A ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.

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. EVENT DATE AND INITIAL REPORTER WERE UNKNOWN.

Additional Manufacturer Narrative

SUPPLEMENTAL REPORT IS BEING FILED DUE TO THE MANUFACTURER NAME AND ADDRESS IN D3, F14, AND G-CONTACT OFFICE MANUFACTURING SITE ON THE INITIAL REPORT 1423537-2025-00231 WERE ENTERED INCORRECTLY. THE CORRECT MANUFACTURER NAME AND ADDRESS ARE NOW BEING SUBMITTED IN THOSE FIELDS. NO OTHER CHANGES TO THE REPORT ARE REQUIRED.