FDA.reportPublic FDA data

MAUDE MDR 4215361

MDR report key
4215361
Report number
2025816-2014-00097
Event key
0
Event type
3
Date of event
2014-06-26
Date received
2014-08-12
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
TERRY SCESNY
Address
4455 ATHERTON DR. SALT LAKE CITY UT 84123 US
Phone
801-801-8012
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CATH LAB KITCATH LAB KITICU MEDICAL, INC.OES46087-3746087-372869345N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-08-120

Event Narratives#

D

Patient 1

COMPLAINT RECEIVED REPORTING AIR IN LINE/COMPONENT ISSUES WITH USE OF ONE 46087-37 CATH LAB KIT. IT WAS REPORTED THAT THE 46087-37 ".. MANIFOLD WAS PREPPED AND AFTER FIRST CATHETER WAS INSERTED, AIR WAS INTRODUCED INTO THE CLOSED SYSTEM VIA THE CONTRAST STOPCOCK". THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES AND OR OUTCOMES. DEVICE RETURN: PENDING.

N

Patient 1

INITIAL INVESTIGATION: A REVIEW OF THE MFG. LOT BUILD DATABASE FOR THE REPORTED LOT # 2869345 (MFG. DATE 05/2014) SHOWS (B)(4) UNITS WERE MFG. TESTED INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE MFG. LOT BUILD.