FDA.reportPublic FDA data

MAUDE MDR 8324879

MDR report key
8324879
Report number
8324879
Event key
0
Event type
3
Date of event
2019-01-30
Date received
2019-02-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MEDEX KIDS KIT CLOSED BLOOD SAMPLING SYSTEMARTERIAL BLOOD SAMPLING KITSMITHS MEDICAL ASD, INCCBTMX4133* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-02-110

Event Narratives#

D

Patient 1

REGISTERED NURSE REPORTED AIR ENTERING THE UMBILICAL ARTERIAL CATHETER VIA THE KIDS KIT ACCESS PORT. THIS WAS IDENTIFIED WHEN ATTEMPTING TO OBTAIN BLOOD FROM THE INFANT VIA THE KIDS KIT ACCESS PORT USING A NEEDLELESS SYRINGE. IF THE AIR CANNOT BE PULSED OUT, THE TUBING HAS TO BE CHANGED. THIS REQUIRES DISCARDING THE INFANT'S BLOOD THAT HAS BEEN PULLED BACK INTO THE CLOSED SYSTEM. THIS DISCARDED AMOUNT CAN BE SIGNIFICANT DUE TO THE SIZE OF THE INFANT.