FDA.reportPublic FDA data

MAUDE MDR 9848047

MDR report key
9848047
Report number
3003639970-2020-00168
Event key
0
Event type
3
Date received
2020-03-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS S OR
Address
CARRETERA DE TERRASSA, 121 RUB 08191 SP
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MONOMAX VIOLET 2/0 (3) 150CM HR26SYNTHETIC ABSORBABLE MONOFILAR SUTUREB. BRAUN SURGICAL, S.A.NWJB0041444B0041444118441Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-180

Event Narratives#

N

Patient 1

ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE HAVE RECEIVED TWO CASES REGARDING THE SAME ISSUE FROM THE SAME CUSTOMER (THIS REPORT IS FOR THE FIRST CASE). WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED 5 CLOSED SAMPLES FOR ANALYSIS TO ANALYZE BOTH CASES. TIGHTNESS TEST TO THE SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 3.81 KGF IN AVERAGE AND 3.46 KGF IN MINIMUM (EP REQUIREMENTS: 2.73 KGF IN AVERAGE AND 1.37 KGF IN MINIMUM). REVIEWED THE BATCH MANUFACTURING RECORD OF THIS PRODUCT, THERE ARE NO INCIDENCES RELATED TO THIS ISSUE AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. REMARKS: WHEN WORKING WITH MONOMAX SUTURE MATERIALS GREAT CARE SHOULD BE TAKEN TO ENSURE THAT THE USE OF SURGICAL INSTRUMENTS, SUCH AS TWEEZERS AND NEEDLE HOLDERS DO NOT DAMAGE THE MATERIAL BY BEING PINCHED OR KINKED. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFIL THE SPECIFICATIONS OF EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. ACTIONS ON PRODUCT DISTRIBUTED OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

D

Patient 1

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH MONOMAX SUTURE. THE CLIENT REPORTED THAT THE THREAD BREAKS VERY EASILY WHEN KNOTTING. IT OCCURRED DURING ABDOMINAL CLOSURE IN TWO DIFFERENT SURGERIES AND TWO DIFFERENT SURGEONS. NO DELAY IN SURGERY AND PATIENT OUTCOME AS GOOD (THIS REPORT IS FOR THE FIRST PATIENT). ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED.