FDA.reportPublic FDA data

MAUDE MDR 9908327

MDR report key
9908327
Report number
3012307300-2020-02435
Event key
0
Event type
3
Date received
2020-03-31
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
DAVE HALVERSON
Address
6000 LANE N MINNEAPOLIS, MN US
Phone
383-383-3833
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CADD MS3 GRAY SLATEPUMP, INFUSIONSMITHS MEDICAL ASD,INCFRN740021-7411-51Y R

Patients#

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

Event Narratives#

N

Patient 1

INVESTIGATION COMPLETED ON A SMITH MEDICAL CADD MS3 PUMP. THE COMPLAINT VERIFIED WHEN TESTED, THIS WAS ISOLATED TO A LOOSE PIECE OF SYRINGE PART WAS STUCK INSIDE THE DRIVE ROD, WHICH RESULTED IN FUNCTIONAL TESTING ERROR. NO INFORMATION OF EVENT IN THE EVENT LOG. THE DEVICE PHYSICAL APPEARANCE WAS IN OVERALL GOOD CONDITION. UNKNOWN WHAT CAUSED EVENT AND ONCE THE MATERIAL WAS RELEASED THE DEVICE PASSED ALL FUNCTIONAL TESTING.

D

Patient 1

INFORMATION RECEIVED A SMITHS MEDICAL CADD MS3 GRAY SLATE PUMP PER MEDWATCH FORM PUMP ALARMING FOR BLOCKAGE DETECTED. NO DELIVERY AND TO CHECK TUBING. NO PATIENT ADVERSE EVENTS REPORTED. NO FURTHER INFORMATION.