FDA Adverse Event Other Summary report: N

CARDINAL HEALTH FOLEY CATHETER, 100% SILICONE

MDR report key: 2654209 · Received June 14, 2012

Report

Report Number
9710011-2012-00001
Event Type
Other
Date Received
June 14, 2012
Date of Event
April 22, 2012
Report Date
May 14, 2012
Manufacturer
SHANGHAI AMSINO MEDICAL DEVICES CO., LTD.
Product Code
EZL
PMA / PMN Number
K051059
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

EVENT DESCRIPTION RECEIVED FROM DISTRIBUTOR MEDWATCH REPORT 0502280000-2012-8002: PT UNDERWENT CERVICAL SURGERY RELATED TO CERVICAL STENOSIS. A LATEX FOLEY CATHETER WAS INSERTED IN THE OPERATING ROOM PRIOR TO THE PROCEDURE AND WAS DISCONTINUED POST OPERATIVELY IN THE POST ANESTHESIA CARE UNIT. PT TRANSFERRED TO THE STEP DOWN UNIT AND WAS NOTED TO HAVE NO VOID POST FOLEY REMOVAL. A SILICONE FOLEY WAS INSERTED. DUE TO LOW URINE OUTPUT THE PT RECEIVED A BLADDER SCAN SHOWING 800 PLUS CC OF URINE. THE FOLEY WAS IRRIGATED WITH 30 CC WATER AND ONE LITER OF BLOOD TINGED URINE CAME OUT. BLOOD WAS ALSO NOTED AT THE PT'S MEATUS. PHYSICIAN WAS NOTIFIED AND ASSESSED THE PT. A UROLOGY CONSULT WAS OBTAINED. THE UROLOGY CONSULT DOCUMENTED THE PT'S HEMATURIA WAS SECONDARY TO TRAUMATIC FOLEY PLACEMENT WITH THE CATHETER IN THE PROSTATE. THE FOLEY WAS REPLACED WITH A 3 WAY LATEX FOLEY FOR CONTINUOUS BLADDER IRRIGATION FOR 24-48 HOURS. MODERATE AMOUNTS OF CLOTS WERE IRRIGATED INITIALLY AND THEN URINE CLEARED VERY QUICKLY. THE 3 WAY FOLEY WAS LEFT IN PLACE FOR 3-4 DAYS THEN REMOVED. POST VOID RESIDUALS WERE CHECKED AND NOTED TO BE LESS THAN 100 CC. PT WAS VOIDING CLEAR, YELLOW URINE WITHOUT DIFFICULTY UPON DISCHARGE FROM HOSPITAL. UROLOGIST STATED THAT UNDER CYSTOSCOPY, THERE WAS NO BENIGN PROSTATIC HYPERTROPHY OR STRUCTURE THAT MAY HAVE CAUSED A PROBLEM WITH THE CATHETER. IT WAS STATED THAT THE HARDNESS OF THE CATHETER ERODED THROUGH THE URETHRAL INTO THE PROSTATE. IT WAS STATED ANECDOTALLY THAT THE UROLOGY SERVICE HAS RECEIVED 3-4 CONSULTS RELATED TO FOLEY CATHETERS AND DIFFICULTY WITH PLACEMENT. PLACEMENT AND ATTEMPTS AT PLACEMENT OF THE FOLEYS HAD BEEN DONE BY STAFF WITH YEARS OF EXPERIENCE. IT WAS NOTED THAT SILICONE FOLEYS USED ON THE FLOOR, VERSUS LATEX FOLEYS USED IN THE OPERATING ROOM, ARE MORE STIFF THAN THEIR LATEX COUNTERPART AND THE STIFFNESS MAY BE CAUSING DIFFICULTY OR TRAUMA DURING PLACEMENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CARDINAL HEALTH FOLEY CATHETER, 100% SILICONE FOLEY CATHETER EZL SHANGHAI AMSINO MEDICAL DEVICES CO., LTD. CS-5-15 23214JD

Patients

Seq Age Sex Outcome Treatment
1 39 YR Other