FDA.reportPublic FDA data

MAUDE MDR 9757742

MDR report key
9757742
Report number
3003639970-2020-00124
Event key
0
Event type
3
Date of event
2020-01-25
Date received
2020-02-26
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 SALUD ORUS
Address
121 CARRETERA DE TERRASSA RUBI, 08191 SP
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SILKAM BLACK 3/0 (2) 75CM HR26OTHER SUTUREB. BRAUN SURGICAL SAGAPC0760412C0760412619293Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-260

Event Narratives#

N

Patient 1

K990089 PMA/510K: REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. ANALYSIS AND RESULTS: THERE IS ONE PREVIOUS COMPLAINT OF THE SAME CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 6,012 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED 72 CLOSED SAMPLES FOR ANALYSIS. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF ALL SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 1.18 KGF IN AVERAGE AND 1.02 KGF IN MINIMUM (EP REQUIREMENTS: 0.92 KGF IN AVERAGE AND 0.31 KGF IN MINIMUM). NEVERTHELESS, WE HAVE ALSO TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS DO NOT FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLED USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE RESULTS OF SAMPLES RECEIVED DO NOT FULFIL THE SPECIFICATIONS OF THE EUROPEAN PHARMACOPOEIA/B. BRAUN SURGICAL SPECIFICATIONS CONCERNING NEEDLE ATTACHMENT STRENGTH, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED. 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 BLACK. THE CUSTOMER REPORTED THE NEEDLE IS DETACHED FROM THE THREAD WHEN LOADING THE SUTURE IN THE HOLDER AND DURING STOMACH SURGERY. THE THREAD ALSO BROKE WHEN IS LOADED IN THE HOLDER. IT HAS HAPPENED TO 3 DIFFERENT NURSES AND A SURGEON.