MEDEX KIDS KIT CLOSED BLOOD SAMPLING SYSTEM MX4133

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-11 for MEDEX KIDS KIT CLOSED BLOOD SAMPLING SYSTEM MX4133 manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[135709253] Infant with umbilical artery catheter in place attached to a smiths medical closed blood sample kit. Concern noted during blood collection. Blood was pulled back into the closed system tubing to allow for a specific amount of waste before aspirating blood from the port for lab work. When aspirating the blood, air was noted to enter the syringe which affected the sample. Registered nurse reported there appeared to be air trapped under the port. There is concern that air entered the line via the kid's kit needleless port device. It was reported the correct procedure for collecting the blood sample was followed. The syringe was appropriately attached to the blunt cannula and the blunt cannula was inserted into the kid's kit port. If air enters the line, the tubing has to be replaced which includes discarding the infant's blood that has been pulled back into the closed system. This discard amount can be significant due to the premature infant's size. In this case, the air was pulsed out of the tubing using sterile technique and then reattached to the infant.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8324898
MDR Report Key8324898
Date Received2019-02-11
Date of Report2019-02-04
Date of Event2019-01-13
Report Date2019-02-04
Date Reported to FDA2019-02-04
Date Reported to Mfgr2019-02-11
Date Added to Maude2019-02-11
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMEDEX KIDS KIT CLOSED BLOOD SAMPLING SYSTEM
Generic NameARTERIAL BLOOD SAMPLING KIT
Product CodeCBT
Date Received2019-02-11
Catalog NumberMX4133
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.
Manufacturer Address201 WEST QUEEN ST. SOUTHINGTON CT 06489 US 06489


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-11

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