FDA.reportPublic FDA data

MAUDE MDR 6390982

MDR report key
6390982
Report number
1121308-2017-00003
Event key
0
Event type
3
Date received
2017-03-09
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
USER SONIA IRIZARRY
Address
311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US
Phone
609-609-6099
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FLOWABLE WOUND MATRIXFWDINTEGRA LIFESCIENCES CORPORATIONKGNFWD301111000177058R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-03-090

Event Narratives#

N

Patient 1

TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

D

Patient 1

IT WAS REPORTED THAT WHEN THE FLOWABLE WOUND MATRIX WAS SOLD, WAS EXPIRED. THE EXPIRATION DATE NOVEMBER 30, 2016, SOLD TO ACCOUNT JANUARY 2, 2017. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

N

Patient 1

ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP ON APRIL 11, 2017; "THIS PRODUCT WAS NOT USED IN A PATIENT. I MEANT TO WRITE THESE OFF AS SAMPLES NOT USED CLINICALLY BUT MADE A MISTAKE WHEN CLOSING OUT THE CHARGE SHEET IN (B)(6)." INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON APRIL 16, 2017. THE INVESTIGATION INCLUDED: METHODS: REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: THE FAILURE IS UNCONFIRMED, AS THE FLOWABLE PRODUCT WAS NOT RETURNED BACK FOR FAILURE ANALYSIS. DHR REVIEW; DHR REVIEW CONFIRMS THAT FLOWABLE WOUND MATRIX 3 CC LOT 105N00325986 EXPIRED ON 11-2016. THE MANUFACTURING MONTH/YEAR OF THIS LOT IS MAY/2015 (CALCULATED FROM THE DATE OF STERILIZATION) AND THE EXPIRY IS NOVEMBER/2016. THERE IS NO INDICATION THAT THE PRODUCTION PROCESS AT INTEGRA COULD HAVE CONTRIBUTED TO THIS COMPLAINT. COMPLAINTS HISTORY; A TRACKWISE QUERY WAS PERFORMED USING THE KEYWORDS ?EXPIR? AND ?EXPIRE? FOR COMPLAINTS ISSUED WITHIN FROM 24-FEB-2016 THROUGH 24-FEB-2017 AND NO ADDITIONAL COMPLAINTS WERE FOUND RELATED TO FLOWABLE PRODUCTS. A LOT QUERY WAS PERFORMED FOR THE 105 SYRINGE LOT 105N00325986, USING THE TRACKWISE COMPLAINTS DATABASE. NO ADDITIONAL COMPLAINTS WERE FOUND FOR THIS LOT. THERE HAVE BEEN APPROXIMATELY (B)(4) FLOWABLE UNITS SOLD IN THE PAST 12 MONTHS. AS PER THE TRENDING QUERIES, THERE HAS BEEN ONLY (B)(4) COMPLAINT IDENTIFIED FOR EXPIRED PRODUCT SOLD (CURRENT COMPLAINT) FROM THE FLOWABLE PRODUCT FAMILY. THEREFORE, THE CALCULATED COMPLAINT RATE IS (B)(4)%. CONCLUSION: (ROOT/CAUSE): THE ROOT CAUSE OF THIS COMPLAINT IS HUMAN ERROR. THE MOST PROBABLE CAUSE OF THIS COMPLAINT IS THE ERROR IN THE CHARGE SHEET THAT THE SALES SPECIALIST COMPLETED. THIS WAS INDICATED BY THE SALES INDIVIDUAL AS STATED IN THE ADDITIONAL INFORMATION OF THE COMPLAINT. THE EXPIRATION DATE OF THE FLOWABLE UNIT WAS EVIDENT AND MEANT TO BE CHARGED AS CLINICAL SAMPLES. IN THE CASE THAT THEY WERE SOLD, THE SALES SPECIALIST LIKELY DID NOT VERIFY THE EXPIRY PRIOR TO DISTRIBUTING IT TO THE CUSTOMER, AS THE PRODUCT UNIT WAS DOCUMENTED AS SOLD TO THE CUSTOMER ON (B)(6) 2017, PER THE COMPLAINT BACKGROUND; AND THE PRODUCT EXPIRED ON NOV-2016.