TDOC-7FS 7F SINGLE SENSOR CATHETER
Received Dec 23, 2013 · Event occurred Nov 25, 2013
Report 1722684-2013-00002 · MDR key 3716531
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
UNK
- Urinary Tract Infection
Narrative
Description of Event or Problem
ON (B)(4) 2013, IT WAS REPORTED TO US THAT "THE CUSTOMER IS SUSPECTING THE CATHETERS ARE RESPONSIBLE FOR 5 PTS HAVE DIFFICULTY VOIDING AFTER UDS PROCEDURE. ONE PT HAS BEEN DIAGNOSED WITH A POSITIVE UTI. DR (B)(6) IS VERY CONCERNED AND HAS NOT KEPT ANY OF THE CATHETERS USED ON PTS. THEY DO HAVE SOME CATHETERS WITH THE SAME LOT NUMBER AVAILABLE TO RETURN FOR INVESTIGATION."
Additional Manufacturer Narrative
UPON RECEIPT OF THIS COMPLAINT, WE EVALUATED THE FOLLOWING DATA: STERILIZATION VALIDATION. STERILIZATION RECORD FOR THE LOT IN QUESTION. (B)(4) MONITORING RECORDS FOR AREA OF PRODUCTION. PULL-TEST DATA FOR PACKAGE. BIOBURDEN/DOSE AUDITS. PULL-TEST DATA FOR CATHETERS RETURNED FOR EVALUATION. NONE OF THE DATA REVIEW PRESENTED PARAMETERS THAT WERE OUT OF SPECIFICATION FOR THIS PRODUCT. ROOT CAUSE OF ISSUE IS UNKNOWN.