FDA.reportPublic FDA data

MAUDE MDR 9908301

MDR report key
9908301
Report number
3012307300-2020-02640
Event key
0
Event type
3
Date of event
2020-01-28
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 N MINNEAPOLIS,, MN US
Phone
383-383-3833
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1JELCO? IV CATHETERCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYSSMITHS MEDICAL ASD; INC.FOZ4038-AI3738126N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. R

Event Narratives#

D

Patient 1

INFORMATION WAS RECEIVED INDICATING THAT UPON REMOVAL OF A SMITHS MEDICAL JELCO IV CATHETER, THE CANNULA BROKE OFF IN THE PATIENT. THE PATIENT WAS REPORTED TO BE TAKEN TO SURGERY FOR SUCCESSFUL REMOVAL OF THE RETAINED PIECE. THE PATIENT RECOVERED AND WAS DISCHARGED. THERE WERE NO FURTHER REPORTED ADVERSE EFFECTS.