MEDLINE SILICONE-ELASTOMER COATED LATEX FOLEY CATHETER

Description of Event or Problem

PRODUCT WAS OBTAINED FROM ARCHCARE HOME CARE AS MONTHLY SUPPLY COVERED BY MEDICARE IN MAY 2026. THIS IS A FOLEY CATHETER FROM MEDLINE SILICONE-ELASTOMER COATED LATEX FOLEY CATHETER 2 WAY 22 FR. WITH 10 ML BALLOON. I AM A REGISTERED NURSE CARING FOR MY SON WHO IS A C 3 - 4 QUADRIPLEGIC FOR PASSED 17 YRS. HE USES INDWELLING URINARY CATHETERS VIA A SUPRAPUBIC APPROACH. 3 DAYS AFTER THIS NEW INSERTION, HE DEVELOPED AUTONOMIC DYSREFLEXIA WHICH IS A SEVERE FORM OF SUDDEN SEVERE HYPERTENSION THAT CAN OCCUR IN SOMEONE WITH A SPINAL CORD INJURY WHEN A NOXIOUS STIMULUS HAS OCCURRED GENERALLY DUE TO A FULL BLADDER WHEN A CATHETER IS NOT DRAINING. BP REACHED 250/130 WITH SEVERE POUNDING HEADACHE FLUSHING OF SKIN AND DIZZINESS. THIS LEADS TO STROKE AND DEATH IF NOT RESOLVED. IT IS ALSO TREATED WITH NITROPASTE APPLICATION AND NIFEDIPINE. WE, MY HUSBAND AND I WHO IS ALSO A REGISTERED NURSE TROUBLESHOOTED THE ISSUE. THE NOXIOUS STIMULI WAS THIS CATHETER NOT DRAINING AND AN OVERFILLED URINARY BLADDER. WE WERE UNABLE TO IRRIGATE IT, WITHDRAW URINE OR WITHDRAW FLUID FROM THE BALLOON TO REMOVE IT. WE WITH GREAT DIFFICULTY DURING THIS EMERGENCY EVENT GOT MY SON BACK TO BED AND FORCEFULLY WITHDREW URINE WITH A PISTON SYRINGE AND STILL COULD NOT DEFLATE THE BALLOON. WITH GREAT EFFORT AFTER SEVERAL ATTEMPTS THE BALLOON DID DEFLATE AND I REMOVED THE CATHETER AT WHICH POINT MY SON'S BLADDER EMPTIED INTO THE BED WITH RELIEF OF SYMPTOMS. HE COULD HAVE DIED AS THAT IS THE END POINT OF AUTONOMIC DYSREFLEXIA. IN SEARCHING COMPLAINTS WITH MEDLINE URINARY CATHETERS, THIS URINARY CATHETER HAS COMPLAINTS DATING BACK TO 2020 YET FOUND ITS WAY INTO OUR HOME HERE IN 2026. IT IS STILL IN CIRCULATION AND NEEDS TO BE REMOVED. THINKING THIS WAS A FLUKE AND ONE TIME EVENT, I INSERTED A NEW MEDLINE CATHETER. IN 3 DAYS THE SAME CRISIS EVENT OCCURRED! THIS HAS NEVER OCCURRED BEFORE WITH OTHER BRANDS OF CATHETERS. I WILL TAKE LEGAL ACTION FOR ALLOWING THIS PRODUCT TO REMAIN ON THE MARKET WITH MULTIPLE COMPLAINTS PENDING FOR 6 YRS RUNNING. THIS REPORT CAPTURES MEDLINE SILICONE-ELASTOMER COATED LATEX FOLEY CATHETER #1. HECC: 1908; 1880; 2153; 2194; 2119. DPC: 2991; 4060; 1536; 3023. REFERENCE REPORT: MW5190200.