AIRCON XL 3000 AIR CONTRAST KIT WITH

Description of Event or Problem

CUSTOMER REPORTED VIA PHONE THAT A PT HAD EXPERIENCED AN ADVERSE EVENT DURING A PROCEDURE INVOLVING POLIBAR BARIUM PRODUCT AND OUR EMPTY AIRCON XL 3000 BARIUM PRODUCT DEVICE. CUSTOMER REPORTS, "A FEMALE WAS HAVING A BARIUM ENEMA WITH E Z EM POLIBAR PRODUCT, INTRODUCED THROUGH THE AIRCON XL 3000 ENEMA KIT. TOTAL VOLUME OF POLIBAR PRODUCT INTRODUCED INTO THE PT WAS APPROXIMATELY 1200CC'S. PT EXPERIENCED NO PROBLEMS DURING THE PROCEDURE. AFTER THE PROCEDURE WAS COMPLETED, STAFF NOTICED HIVES PRESENT ON PT. PT WAS GIVEN A 25 MG BENADRYL TABLET AND OBSERVED FOR ONE HOUR. HIVES RESOLVED AND RADIOLOGY DISCHARGED PT WITH NO FURTHER INSTRUCTIONS." CUSTOMER CONTACTED COVIDIEN TO INQUIRE ABOUT LATEX CONTENT OF THE AIRCON XL TO HELP ASSESS PT SYMPTOMS, PRODUCT DID NOT MALFUNCTION. AIRCON XL PRODUCT IS LATEX FREE.

Additional Manufacturer Narrative

ROOT CAUSE IDENTIFIED: ROOT CAUSE CAN NOT BE DETERMINED SINCE DEFECT WAS NOT CONFIRMED. CONCLUSION: DEVICE HISTORY RECORD WAS NOT REVIEWED SINCE THE LOT NUMBER WAS NOT PROVIDED. CORRECTIVE ACTIONS: NO CORRECTIVE ACTIONS WILL BE APPLIED. THE PART OF THE PRODUCT AIRCON XL 3000 WHICH IS INSERTED INTO PT IS THE AIR CONTRAST SAFETY TIP WITH SILICONE RETENTION CUFF. THIS PART NUMBER IS ASSEMBLED WITH SILICONE SAFETY CUFF, WHICH MATERIAL IS SILICONE, AND, SAFETY ENEMA TIP BODY WHICH MATERIAL IS BLUE PVC. THESE BOTH ARE PROVIDED BY AN EXTERNAL VENDOR. DEFECT CAN NOT BE CONFIRMED SINCE THE DEFECTIVE SAMPLE WAS NOT RECEIVED FOR EVALUATION. IN THE CONTRAINDICATIONS OF THIS PRODUCT; IT IS STATED. DO NOT USE THIS PRODUCT IN PTS WITH SUSPECTED GASTROINTESTINAL TRACT PERFORATION OR KNOWN HYPERSENSITIVITY TO BARIUM SULFATE FORMULATIONS. IF SAMPLE IS RECEIVED THIS COMPLAINT WILL BE REOPENED FOR REVIEW.