TRAY,IRR PISTON SYR, 0.9% STRL SALINE

Additional Manufacturer Narrative

THE MANUFACTURER RECEIVED FIVE (5) UNUSED SAMPLES FROM THE REPORTING FACILITY. THE UNUSED SAMPLES WERE FROM LOT 19CAB954, HOWEVER, THE LOT NUMBER OF THE IRRIGATION PISTON SYRINGE AND TRAY INVOLVED IN THE REPORTED INCIDENT IS UNKNOWN. VISUAL INSPECTION OF THE SAMPLES WAS PERFORMED AND IT WAS NOTED THAT ALL SEALS APPEARED VISUALLY INTACT. FUNCTIONAL INSPECTION OF THE SEALS WAS PERFORMED USING BLUE DYE PER ASTM F1929-15 AND ALL SEALS WERE FOUND TO BE INTACT ON ALL SAMPLES RECEIVED. THERE WERE ADDITIONALLY NO NOTED VISUAL DEFECTS OR ABNORMALITIES OF THE TRAY COMPONENTS. A ROOT CAUSE FOR THE REPORTED INCIDENT WAS UNABLE TO BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE ANOTHER SUPPLEMENTAL MEDWATCH WILL BE FILED.

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE PATIENT USED THE IRRIGATION PISTON SYRINGE TO PERFORM CATHETER IRRIGATIONS. IT IS UNKNOWN HOW MANY TIMES THE IRRIGATION PISTON SYRINGE INVOLVED IN THIS INCIDENT WAS USED FOR CATHETER IRRIGATION. IT WAS REPORTED THAT THE PATIENT PRESENTED TO A LOCAL HOSPITAL WITH FEVER, FATIGUE, AND LETHARGY. HE WAS DIAGNOSED WITH A URINARY TRACT INFECTION (UTI) AND WAS HOSPITALIZED. HE REPORTEDLY RECEIVED IV CEFTAZIDIME AND VANCOMYCIN TO TREAT THE UTI. NO ADDITIONAL DIAGNOSTIC EXAMS/RESULTS OR MEDICAL TREATMENT(S) WERE REPORTED TO THE MANUFACTURER. NO SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. A ROOT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE IDENTIFIED. DUE TO THE REPORTED HOSPITALIZATION AND NEED FOR ANTIBIOTIC TREATMENT, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT EXPERIENCED A URINARY TRACT INFECTION (UTI), WAS HOSPITALIZED, AND TREATED WITH ANTIBIOTICS.