FDA.reportPublic FDA data

MAUDE MDR 9843317

MDR report key
9843317
Report number
1018120-2020-00409
Event key
0
Event type
3
Date of event
2020-03-02
Date received
2020-03-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JILL SARAIVA
Address
15 HAMPSHIRE STREET MANSFIELD MA 02048 US
Phone
508-508-5086
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
16939 SPG GZ 4X4-12 STR 10'SFIBER, MEDICAL, ABSORBENTCOVIDIENFRL6939693920A054962N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-170

Event Narratives#

N

Patient 1

THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. PHYSICAL SAMPLES WERE NOT RECEIVED FOR THE INVESTIGATION AS THE PRODUCT HAS BEEN DISCARDED. FOUR PHOTOS WERE PROVIDED FOR EVALUATION. A VISUAL ANALYSIS WAS COMPLETED, AND THE REPORTED ISSUE WAS CONFIRMED. IT IS CLEAR FROM THE PHOTOS THAT THE GAUZE HAD LOOSE FIBERS FRAYING OUT. FRAYING IS A CONDITION WHEREBY THE PRODUCT EXHIBITS EXCESS FIBERS SEPARATING FROM THE PRODUCT TYPICALLY AROUND THE OUTER EDGES OR AREAS WHERE THE PRODUCT HAS BEEN CUT OR SLIT. THIS IS WHERE THE GAUZE TENSILE STRENGTH IS WEAK IN THAT PART OF THE CONSTRUCTION OF THE MATERIAL. SAMPLING PLANS ARE IN PLACE FOR PRODUCTION AT BEGINNING, MIDDLE AND ENDING OF THE LOTS FOR DEFECTS, FRAYING IS ONE OF THE CHECKS THAT IS DONE ON EVERY LOT. WITHOUT A SAMPLE FOR EVALUATION A ROOT CAUSE COULD NOT BE DETERMINED, THEREFORE APPROPRIATE CORRECTIVE ACTION TO ADDRESS THE ISSUE CANNOT BE IMPLEMENTED. A REMEDIATION TEAM IS BEING PUT TOGETHER TO REVIEW THIS COMPLAINT. FUNCTIONAL TESTING AND VISUAL INSPECTIONS ARE BEING PERFORMED ACCORDING TO OUR CURRENT QUALITY STANDARDS AND INSPECTION PROCEDURES. THIS COMPLAINT WILL BE USED FOR QA TRACKING AND TRENDING PURPOSES.

D

Patient 1

THE CUSTOMER REPORTED THAT THE GAUZE WAS FRAYING. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER STATED THAT THEY USE THE GAUZE TO WIPE MULTIPLE WIRES/CATHETERS THAT ARE ENTERING THE PATIENT THROUGH A SHEATH DURING A CEREBRAL ANGIOGRAM.