FDA.reportPublic FDA data

MAUDE MDR 7648740

MDR report key
7648740
Report number
3006260740-2018-01534
Event key
0
Event type
3
Date received
2018-06-28
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
TESHA UDY
Address
605 N. 5600 W. SALT LAKE CITY UT 84116 US
Phone
801-801-8015
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1STATLOCK ARROW ARTERIAL RETAINER, SELECT PADS 50 BOXDEVICE, INTRAVASCULAR CATHETER SECUREMENTBARD ACCESS SYSTEMSKMKART0423JUCQF032R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-06-280

Event Narratives#

N

Patient 1

THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) OF JUCQF032 SHOWED TWO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (JUCQF032) HAVE BEEN REPORTED FROM THE SAME FACILITY.

D

Patient 1

IT WAS REPORTED THAT THIS FACILITY USED 3 STATLOCKS THAT "DIDN'T HAVE VERY GOOD ADHESIVE." NO PATIENT INJURY REPORTED. THIS FILE ADDRESSES THE SECOND OF THE THREE DEVICES.