FDA.reportPublic FDA data

MAUDE MDR 9907860

MDR report key
9907860
Report number
3003639970-2020-00174
Event key
0
Event type
3
Date of event
2019-06-12
Date received
2020-03-31
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
1SAFIL VIOLET 0 (3.5) 90CM HR37S (M)SYNTHETIC ABSORBABLE BRAIDED SUTUREB. BRAUN SURGICAL, S.A.GAMC1048956C1048956117487R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE (B)(4) UNITS IN OUR STOCK. WE HAVE NOT RECEIVED ANY SAMPLE FROM THE CUSTOMER. WE HAVE REQUESTED ONE BOX (36 CLOSED SAMPLES) FROM STOCK FOR ANALYSIS. TIGHTNESS TEST TO THE SAMPLES OF OUR STOCK HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED FROM STOCK AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 5.34 KGF IN AVERAGE AND 4.89 KGF IN MINIMUM (EP REQUIREMENTS: 3.98 KGF IN AVERAGE AND 1.89 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 REQUIREMENT FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FROM STOCK 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 SAFIL VIOLET SUTURE. ON (B)(6) 2019, AT 9 A.M., THE PATIENT WAS THREATENED WITH LABOR DUE TO SCARRED UTERUS AND UNDERWENT LOWER UTERINE SEGMENT CAESAREAN SECTION. ABSORBABLE SURGICAL NEEDLE SUTURE (SAFIL VIOLET) WAS USED TO SUTURE THE WOUND. DURING THE SUTURE PROCESS, THE MIDDLE SEGMENT OF THE SUTURE SUDDENLY BROKE, AND THE DOCTOR STOPPED USING IT IMMEDIATELY AFTER DISCOVERING IT. THE NURSE IMMEDIATELY TOOK A NEW PACK OF ABSORBABLE SURGICAL NEEDLE SUTURES. THE WOUND SUTURE WAS SUCCESSFULLY COMPLETED. .