BARDEX® ALL-SILICONE FOLEY CATHETER

Description of Event or Problem

IT WAS REPORTED THAT CUSTOMER WAS ASKED TO ASSIST WITH PLACING AN INDWELLING FOLEY CATHETER FOR THE PATIENT WHO HAD BEEN RETAINING URINE AND REQUIRING STRAIGHT CATHETERIZATIONS THAT HAD CAUSED LABIAL OR GENITAL SWELLING. THE PATIENT HAS AN ALLERGY TO LATEX, SO THEY WERE REQUIRING SILICONE INDWELLING CATHETER. 8B DID NOT HAVE ANY 14F TWO-WAY SILICONE INDWELLING CATHETER KITS. THEY WENT AND TOOK ONE FROM 8C AND TWO FROM 8A. BS REGISTERED NURSE WAS UNABLE TO GET FIRST TWO CATHETERS PLACED, SO THEY DID THE THIRD ATTEMPT, WHICH WAS SUCCESSFUL, BUT THE CATHETER STARTED LEAKING RIGHT AFTER INSERTION, PRIOR TO THE BALLOON BEING FILLED. THEY FILLED THE BALLOON, AND THE CATHETER WAS STILL LEAKING. UPON FURTHER INSPECTION, THEY FOUND A HOLE. THEY FINISHED DRAINING THE PATIENT'S URINE AND PLAN TO PULL THE CATHETER AND SAVE FOR REVIEW. THEY INSPECTED THE OTHER TWO CATHETER THAT WERE NOT SUCCESSFUL AND NEITHER HAD A HOLE BUT, ONE HAD AN INDENTATION IN THE SAME AREA AND THE FIRST, AND THE OTHER HAD A SLIGHT INDENTATION BUT NO HOLE OR OPENING EITHER.

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 WAS ASKED TO ASSIST WITH PLACING AN INDWELLING FOLEY CATHETER FOR THE PATIENT WHO HAD BEEN RETAINING URINE AND REQUIRING STRAIGHT CATHETERIZATIONS THAT HAD CAUSED LABIAL OR GENITAL SWELLING. THE PATIENT HAS AN ALLERGY TO LATEX, SO THEY WERE REQUIRING SILICONE INDWELLING CATHETER. 8B DID NOT HAVE ANY 14F TWO-WAY SILICONE INDWELLING CATHETER KITS. THEY WENT AND TOOK ONE FROM 8C AND TWO FROM 8A. BS REGISTERED NURSE WAS UNABLE TO GET FIRST TWO CATHETERS PLACED, SO THEY DID THE THIRD ATTEMPT, WHICH WAS SUCCESSFUL, BUT THE CATHETER STARTED LEAKING RIGHT AFTER INSERTION, PRIOR TO THE BALLOON BEING FILLED. THEY FILLED THE BALLOON, AND THE CATHETER WAS STILL LEAKING. UPON FURTHER INSPECTION, THEY FOUND A HOLE. THEY FINISHED DRAINING THE PATIENT'S URINE AND PLAN TO PULL THE CATHETER AND SAVE FOR REVIEW. THEY INSPECTED THE OTHER TWO CATHETER THAT WERE NOT SUCCESSFUL AND NEITHER HAD A HOLE BUT, ONE HAD AN INDENTATION IN THE SAME AREA AND THE FIRST, AND THE OTHER HAD A SLIGHT INDENTATION BUT NO HOLE OR OPENING EITHER.

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. INSTRUCTIONS FOR USE WERE REVIEWED FOR THIS INVESTIGATION. THE LABELING IS FOUND TO BE ADEQUATE. AS IT STATES: VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. IF PACKAGE IS OPENED OR IF ANY IMPERFECTION OR SURFACE DETERIORATION IS OBSERVED, DO NOT USE. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. 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.