FDA.reportPublic FDA data

MAUDE MDR 4929010

MDR report key
4929010
Report number
8040412-2015-00160
Event key
0
Event type
3
Date of event
2015-06-19
Date received
2015-07-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JASMINE BROWN
Address
3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US
Phone
919-919-9193
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TRANSURETHRAL CATHETERFOLEY CATHETERTELEFLEX MEDICALFGH171305-00014014LE52R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-07-210

Event Narratives#

D

Patient 1

ALLEGED EVENT: THE INDWELLING CATHETER WAS CUT AT THE LEVEL OF THE CONNECTION. THE BALLOON WAS DEFLATED AND THE CATHETER WAS REMOVED. THE REPORT DESCRIPTION DOES NOT CLEARLY DEFINE IF THE CATHETER WAS BROKEN OR IF THE DEVICE WAS UNABLE TO BE DEFLATED AND HAD TO BE CUT FOR REMOVAL. THE PATIENT'S CONDITION WAS REPORTED AS UNKNOWN.

N

Patient 1

(B)(4). THE DEVICE SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION AT THE TIME OF THIS REPORT.THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

N

Patient 1

(B)(4). THE DEVICE HISTORY RECORD FOR LOT (14LE52) WAS REVIEWED AND NO ISSUE THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. ACTUAL SAMPLE WAS RETURNED FOR INVESTIGATION. IT WAS OBSERVED THAT THE SHAFT OF THE SAMPLE HAD DETACHED FROM ITS FUNNEL. FURTHER EXAMINATION ON THE ACTUAL SAMPLES USING MAGNIFYING LENS (10XMAGNIFICATION) DID NOT REVEAL ANY SIGN OF ABRASION MARK OR SCRATCH TO SUGGEST ANY MANUFACTURING INADEQUACY. BASED ON OUR EXPERIENCE, IT IS VERY UNLIKELY THAT THE CATHETER COULD HAVE DETACHED WITHOUT ANY EXTERNAL FORCE OR EXTERNAL CONTACT. THE TUBE WAS MOLDED USING INJECTION MOLDING MACHINE WHERE TUBE WILL BE PHYSICALLY MOUNTED IN LIQUID SILICONE BEFORE IT GETS HEATED AND MOLDED INSIDE THE FUNNEL. WE DID NOT FIND ANY PROBLEM WITHIN THE PRODUCT, WHICH COULD HAVE CONTRIBUTED FROM MANUFACTURING PROCESSES. THE ACTUAL RETURNED SAMPLE WAS TESTED AND COMPLIED WITH REQUIRED STANDARDS. THEREFORE, WE COULD NOT CONFIRM THIS COMPLAINT.

D

Patient 1

ALLEGED EVENT: THE INDWELLING CATHETER WAS CUT AT THE LEVEL OF THE CONNECTION. THE BALLOON WAS DEFLATED AND THE CATHETER WAS REMOVED. THE REPORT DESCRIPTION DOES NOT CLEARLY DEFINE IF THE CATHETER WAS BROKEN OR IF THE DEVICE WAS UNABLE TO BE DEFLATED AND HAD TO BE CUT FOR REMOVAL. THE PATIENT'S CONDITION WAS REPORTED AS UNKNOWN.