FDA.reportPublic FDA data

MAUDE MDR 6797480

MDR report key
6797480
Report number
2084725-2017-00535
Event key
0
Event type
3
Date of event
2017-05-17
Date received
2017-08-16
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
MR. JOAQUIN KURZ
Address
33 TECHNOLOGY DRIVE IRVINE
Phone
949-949-9497
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1STERRAD? CHEMICAL INDICATOR STRIPCHEMICAL INDICATORADVANCED STERILIZATION PRODUCTSJOJ14100221611-02* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-160

Event Narratives#

N

Patient 1

(B)(4). (B)(6). ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR), TRENDING OF LOT NUMBER, RETAINS TESTING, CONCOMITANT PRODUCT EVALUATION, VISUAL ANALYSIS AND SYSTEM RISK ANALYSIS (SRA). ? THE DHR WAS REVIEWED AND THE INVOLVED LOT MET MANUFACTURER SPECIFICATIONS AT THE TIME OF RELEASE. NO ANOMALIES WERE OBSERVED THAT WOULD CONTRIBUTE TO THE CUSTOMER'S EXPERIENCED ISSUE. ? TRENDING ANALYSIS BY LOT NUMBER WAS REVIEWED FROM 11/22/2016 TO 5/22/2017 AND NO SIGNIFICANT TREND IS OBSERVED. ? THIRTY RETAINS CI STIPS WERE SUBJECT TO FUNCTIONAL EVALUATION. ALL THIRTY CI STRIPS MET SPECIFICATION FOR COLOR CHANGE POST-STERRAD? PROCESSING. ? CONCOMITANT PRODUCT EVALUATION DETERMINED IT IS UNLIKELY THAT THE STERRAD? 100S UNIT CONTRIBUTED TO THE ISSUE SINCE THE CYCLE COMPLETED AND THE REMAINDER OF THE CI STRIP CHANGED COLOR CORRECTLY. ? THE PRODUCT WAS NOT RETURNED; HOWEVER, VISUAL ANALYSIS WAS PERFORMED FROM A PHOTOGRAPH OF THE AFFECTED PRODUCT PROVIDED BY THE CUSTOMER. THE PICTURE CONFIRMS THERE IS A "RED SPOT" ON THE STRIP AND THE REMAINDER OF THE STRIP HAS CHANGED COLOR CORRECTLY. IT COULD NOT BE DETERMINED IF THE RED SPOT WAS A RESULT OF THE CI STRIP BEING BLOCKED DURING STERILIZATION AND THE CUSTOMER WAS UNABLE TO CONFIRM IF THAT WAS THE SITUATION OR NOT. ? THE SRA INDICATES THE RISK ASSOCIATED WITH A EXPOSURE TO BIOHAZARDOUS, PATHOGENIC OR INFECTIOUS MATERIAL IS "LOW." THERE IS INSUFFICIENT INFORMATION TO DETERMINE AN ASSIGNABLE CAUSE. IT IS UNLIKELY THAT THE COLOR-CHEMICAL INDICATOR ISSUE WAS CAUSED BY A MANUFACTURING ISSUE SINCE THE RETAINS PRODUCT MET FUNCTIONAL SPECIFICATION, DHR REVIEW FOUND NO ANOMALIES THAT WOULD CONTRIBUTE TO A INCORRECT COLOR CHANGE AND NO SIGNIFICANT TRENDS WERE FOUND IN LOT TRENDING REVIEW. AN ISSUE WITH STERRAD? PERFORMANCE IS ALSO UNLIKELY SINCE THE CYCLE PASSED AND THE REMAINDER OF THE CI STRIP CHANGED COLOR CORRECTLY. THE CHEMICAL INDICATOR RETAINS MET FUNCTIONAL SPECIFICATION. AS A RESULT, THERE IS NOT AN ISSUE WITH PRODUCT PERFORMANCE WHEN USED PER THE INSTRUCTIONS FOR USE (IFU). THE ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED.

D

Patient 1

A CUSTOMER REPORTED A STERRAD? CHEMICAL INDICATOR STRIP DID NOT CHANGE COLOR CORRECTLY AFTER A COMPLETED STERRAD? 100S CYCLE. THE AFFECTED LOAD WAS RELEASED FOR USE ON PATIENTS. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF STERRAD? CHEMICAL INDICATOR STRIPS NOT CHANGING COLOR CORRECTLY AND THE LOAD IS RELEASED WITHOUT REPROCESSING.