MEDLINE INDUSTRIES, INC.

Description of Event or Problem

PT FULLY DILATED, DR. [REDACTED] AT BEDSIDE FOR BEDSIDE SONO [SONOGRAM] WITH SVE [STERILE VAGINAL EXAMINATION]. UPON PROVIDER EXAM, PROVIDER STATES SHE COULD FEEL THE FOLEY BALLOON CATH AT THE EDGE OF PT URETHRA AND BEHIND BABY HEAD AND FOLEY CATH COMPLETELY DISLODGED AND CAUSE EXTENSIVE URETHRAL TRAUMA. RN AT BEDSIDE WITH DR. [REDACTED]. FOLEY CATH NOTED TO BE PARTIALLY INFLATED, FOLEY BALLON NOTED TO ONLY BE INFLATED WITH 7ML OF FLUID NOT 10 ML (NO LEAKING NOTED ON FOLEY CATH UPON EXAMINATION). PRESSURE APPLY TO URETHRA BY DR. [REDACTED], DR. [REDACTED] AND DR. [REDACTED] AT BEDSIDE FOR ASSESSMENT AND PT STRAIGHT CATH BEFORE PUSHING AND UROLOGY TEAM INVOLVED AFTER PT DELIVERED. PT PUSHED FOR 10 MIN AND ONLY HAD A 1ST DEGREE LACERATION. UNKNOWN IF PRODUCT WAS DEFECTIVE. FOLEY CATHETER PLACED WITH 10ML IN THE BALLOON. FOLEY CATHETER WAS EXPELLED THROUGH THE URETHRA WITH BALLOON INFLATED. VOLUME OF BALLOON WAS CHECKED AFTER EXPULSION AND HAD 7ML IN BALLOON. PRIOR TO THE EXPULSION OF THE FOLEY CATHETER, THE PATIENT WAS IN LABOR AND HER CERVIX FULLY DILATED TO 10CM. OTHER INFO FROM CATHETER PACKAGING: URO175716, (B)(4), EXP:2027-04-30.