FDA.reportPublic FDA data

MAUDE MDR 9764656

MDR report key
9764656
Report number
3003639970-2020-00108
Event key
0
Event type
3
Date of event
2020-01-29
Date received
2020-02-27
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 RUBI, BARCELONA 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 SAGAPC0760412C0760412619285Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-270

Event Narratives#

N

Patient 1

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. K990089. INVESTIGATION: SAMPLES RECEIVED: 112 UNOPENED POUCHES. ANALYSIS AND RESULTS: THERE IS ONE PREVIOUS COMPLAINT OF THE SAME CODE-BATCH. WE MANUFACTURED 6,156 UNITS OF THIS CODE-BATCH. THERE ARE 180 UNITS BLOCKED IN STOCK. WE HAVE RECEIVED 112 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): 1.16 KGF IN AVERAGE AND 0.98 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. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

D

Patient 1

IT WAS REPORTED THAT THERE IS AN ISSUE WITH NEEDLE DETACHMENT. THE REPORTER INDICATED THAT DURING A SURGICAL PROCEDURE THE NEEDLE DETACHED FROM THE THREAD BREAKING VERY EASILY. PATIENT INFORMATION IS NOT AVAILABLE.