FDA.reportPublic FDA data

MAUDE MDR 9865478

MDR report key
9865478
Report number
3003639970-2020-00167
Event key
0
Event type
3
Date received
2020-03-23
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 SILVIA ORUS
Address
CARRETERA DE TERRASSA, 121 RUB 08191 SP
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SILKAM BLACK 3/0 (2) 75CM DS19OTHER SUTUREB. BRAUN SURGICAL, S.A.GAPC0765210C0765210619314Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-230

Event Narratives#

N

Patient 1

ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 6,480 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED 24 CLOSED SAMPLES FOR ANALYSIS. WE HAVE TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 0.80 KGF IN AVERAGE AND 0.53 KGF IN MINIMUM (EP REQUIREMENTS: 0.69 KGF IN AVERAGE AND 0.35 KGF IN MINIMUM). REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. NEEDLE ATTACHMENT STRENGTH RESULTS BEFORE RELEASING THE PRODUCT WERE 1.07 KGF IN AVERAGE AND 0.84 KGF IN MINIMUM AND FULFILLED EP REQUIREMENTS. 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. WE REGRET ANY INCONVENIENCE THIS ISSUE MAY HAVE CAUSED AND THANK YOU FOR YOUR COLLABORATION. 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 SILKAM SUTURE. THE CLIENT REPORTED THAT THE NEEDLE DETACHED FROM THE THREAD AT KNOTTING DURING OPEN SURGERY. IT HAPPENED 3 TIMES, WITH DIFFERENT SUTURES OF THE SAME BOX.