FDA.reportPublic FDA data

MAUDE MDR 9855994

MDR report key
9855994
Report number
2520313-2020-00013
Event key
0
Event type
3
Date of event
2020-03-06
Date received
2020-03-19
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
SUSAN SHERWIN
Address
1 BAYER DRIVE INDIANOLA PA 15051 US
Phone
724-724-7249
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1STELLANT DUAL CT INJECTORCT INJECTION SYSTEMBAYER MEDICAL CARE, INC.DXT85631829SCT FLEXR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1901. R

Event Narratives#

N

Patient 1

BAYER SERVICE VISITED THE CUSTOMER SITE AND REPLACED THE SYRINGE HOUSING, SIZE SENSOR, AND ID BOARD, WHICH RESTORED THE SYSTEM TO NORMAL OPERATION. BAYER SERVICE NOTED THAT THE CUSTOMER HAD DAMAGED THE SYRINGE SIZE SENSOR WHEN ATTEMPTING TO INCORRECTLY RECTIFY THE SITUATION. THE BROKEN SYRINGE WAS DISCARDED BY THE CUSTOMER AND A LOT NUMBER WAS UNABLE TO BE PROVIDED; THEREFORE, TESTING OF A RETAINED SAMPLE IS NOT ABLE TO BE PERFORMED. BAYER PRODUCT ANALYSIS REVIEWED A PHOTOGRAPH OF THE INJECTOR HOUSING TAKEN BY BAYER SERVICE FOLLOWING THE INCIDENT; HOWEVER, THE PHOTOGRAPH WAS INCONCLUSIVE. THE OPERATION MANUAL CONTAINS THE FOLLOWING EXCERPTS FROM THE ELECTRO-MECHANICAL HAZARD AND INSPECTING THE INJECTION SYSTEM SECTIONS. DO NOT REMOVE ANY COVERS OR DISASSEMBLE THE INJECTOR. CONTACT BAYER OR A LOCAL DEALER FOR SERVICE OR REPAIRS.

D

Patient 1

THE FOLLOWING INFORMATION WAS REPORTED TO BAYER: A SYRINGE BROKE WHILE A TECHNOLOGIST WAS ATTEMPTING TO REMOVE THE SYRINGE FROM THE STELLANT FLEX INJECTOR SYSTEM. FOLLOWING THE OCCURRENCE, A PORTION OF THE SYRINGE REMAINED ENGAGED WITHIN THE INJECTOR SYSTEM. THE TECHNOLOGIST USED A PAIR OF SCISSORS TO TRY AND RETRIEVE THE BROKEN PORTION OF THE SYRINGE AND IN DOING SO, PUNCTURED THE PALM OF HIS HAND WITH THE SCISSORS. A SAFETY REPORT WAS FILED AT THE CUSTOMER SITE AND THE TECHNOLOGIST WAS EVALUATED AT OCCUPATIONAL HEALTH THE MORNING AFTER THE INCIDENT OCCURRED. THE TECHNOLOGIST WAS GIVEN A TETANUS SHOT FOR PREVENTION AND INSTRUCTED TO FOLLOW UP WITH OCCUPATIONAL HEALTH AS NEEDED. THE TECHNOLOGIST HAS BEEN REPORTED TO RECOVER AND NO FURTHER TREATMENT HAS BEEN PROVIDED.