FDA.reportPublic FDA data

MAUDE MDR 9908438

MDR report key
9908438
Report number
3012307300-2020-02507
Event key
0
Event type
3
Date received
2020-03-31
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
DAVE HALVERSON
Address
6000 NATHAN LANE NORTH MINNEAPOLIS, MN US
Phone
383-383-3833
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CADD 100 ML MEDICATION CASSETTE RESERVOIRSET, ADMINISTRATION, INTRAVASCULARSMITHS MEDICAL ASD, INC.FPA21-7302-24R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

D

Patient 1

INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CASSETTE HAD A FOLD IN THE BLADDER OF THE CASSETTE WHICH WOULD CAUSE MULTIPLE AIR BUBBLES THAT COULD NOT BE DISPELLED DURING THE RECONSTITUTION PROCESS AND THAT THERE WERE MULTIPLE AIR BUBBLES THAT DESPITE MANIPULATION WITH A SYRINGE, THE AIR BUBBLES WERE CAUGHT IN THE EDGE OF THE BLADDER. THERE WERE NO ADVERSE EVENTS REPORTED.