URINARY CATHETER

Additional Manufacturer Narrative

BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

COMPLAINANT REPORTS WHEN THE DEVICE WAS USED APPROXIMATELY 1 TO 5 MINUTES (EXACT DURAGION OF PRODUCT USAGE IS UNKNOWN) THEY NOTICED THE TIP OF THE CATHETER WAS NOT ROUNDED AND BROKEN. THE COMPLAINANT ALSO REPORTS THERE WAS NO HARM TO THE PATIENT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION HAS BEEN RECEIVED ON AUGUST 13, 2015. DEFECTIVE SAMPLE PICTURE WAS PROVIDED AND INSPECTED, THE DEFECT WAS CONFIRMED, AND CATHETER TIP IS NOT ROUNDED. THE QUALITY OF THE PICTURE IS NOT GOOD; IT IS DIFFICULT TO SEE THE SHAPE OF THE TIP AND THE QUALITY, AND THE SIZE OF PUNCHED EYELETS. THE INFORMATION IMPORTANT FOR THE INVESTIGATION OF REPORTED ISSUE IS NOT POSSIBLE TO OBTAIN FROM THE PICTURE. DHRS OF THE MANUFACTURING FROM ASSEMBLY AUTOMAT A095 THAT WAS PACKED INTO PACKAGING WERE REVIEWED. NO NON-CONFORMANCES RELATED TO REPORTED DEFECT WERE ISSUED. ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND THE FINAL PRODUCT RELEASING WAS CARRIED OUT AND MET THE REQUIREMENTS. THERE IS THE INSPECTION ESTABLISHED THAT IS INTENDED TO DETECT SUCH DEFECTIVE PRODUCTS DURING MANUFACTURING PROCESS. CATHETER TIP IS ROUNDED BY ASSEMBLY AUTOMAT AND THE QUALITY OF TIP IS CHECKED BY AUTOMAT ITSELF. THERE IS THE FLOW SENSOR IN THE AUTOMAT THAT ENSURES THE REJECTION OF ALL CATHETERS WITHOUT ROUNDED TIP. ADDITIONALLY, OPERATORS PERFORM VISUAL INSPECTION OF THE QUALITY OF CATHETER TIP OF ALL MANUFACTURED PRODUCTS. THE HISTORY OF COMPLAINTS HAS BEEN REVIEWED, NO OTHER COMPLAINTS RELATED TO THE SAME PRODUCT ITEM AND THE SAME DEFECT HAS BEEN REGISTERED IN THE COMPLAINT DATABASE SINCE 2014. THE HISTORY OF THE INTERNAL NCS DATABASE HAS BEEN CHECKED, NO SIMILAR DEFECT FOR THE CATHETERS MANUFACTURED ON A095 HAS BEEN RECORDED SINCE 2014. TAKING INTO CONSIDERED AS ISOLATED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON SEPTEMBER 04, 2015. (B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS RECEIVED ON 04/08/2015. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON 04/13/2015.

Description of Event or Problem

ADDITIONAL INFORMATION: INFORMATION WAS RECEIVED THAT THE CATHETER WAS INSERTED INTO THE PATIENT IN 1.5 MINUTES. THIS IS AN INTERMITTENT CATHETER, USED TO DRAIN URINE INTERMITTENTLY.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS RECEIVED ON 08/07/2015. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT RESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO NON-COMFORMITY HAS BEEN REGISTERED DURING THE MANUFACTURING PROCESS OF THE MENTIONED LOT. THERE HAVE NOT BEEN ANY OTHER COMPLAINTS RECEIVED ON THE LOT OR THE REFERENCE CODE WITHIN THE LAST 12 MONTHS. THE PICTURE OF EFFECTED CATHETER WAS PROVIDED AND VISUALLY EVALUATED. THE SAMPLE DID NOT MEET SPECIFICATION. THE TIP OF THE CATHETER WAS NOT ROUNDED. AFTER REVIEWING THE PICTURE OF THE AFFECTED PRODUCT, A DISCREPANCY WAS FOUND. THIS WARRANTS FURTHER ACTION AND A NONCONFORMANCE WILL BE OPENED. NO ADDITIONAL PATIENT/EVENT DETAILS HAE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.