FDA.reportPublic FDA data

MAUDE MDR 8521114

MDR report key
8521114
Report number
2951238-2019-00744
Event key
0
Event type
3
Date received
2019-04-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. CONNIE TUBERA
Address
2400 RINGWOOD AVENUE SAN JOSE CA 95131 US
Phone
408-408-4089
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COLLECTION SET TUBING PVC (10/PK)TUBING SETSEISA MEDICAL SALES, LLCHHI23116S181605Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-160

Event Narratives#

N

Patient 1

THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION; HOWEVER, A PHOTOGRAPHIC IMAGE OF THE STERILE PACKAGING WAS PROVIDED BY THE USER FACILITY. THE IMAGE ILLUSTRATED THE PVC TUBING AND A FOREIGN MATERIAL REMAINED INSIDE THE PACKAGING. SINCE THE PVC TUBING AND ITS STERILE PACKAGING WERE NOT RETURNED THE FOREIGN MATERIAL CANNOT BE CONFIRMED AS ORGANIC. IF THE DEVICE IS RETURNED TO OLYMPUS FOR EVALUATION AT A LATER DATE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

D

Patient 1

OLYMPUS WAS INFORMED THAT DURING SETUP OF THE PROCEDURE, THE UNOPENED PACKAGE OF THE STERILE DEVICE WAS NOTED TO HAVE SOME DEBRIS INSIDE. THE PACKAGE REMAINS SEALED. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY WAS REPORTED.