MEDEX? KIDS KIT? CLOSED BLOOD SAMPLING SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-05-24 for MEDEX? KIDS KIT? CLOSED BLOOD SAMPLING SYSTEM manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[75871183] Potential catalog number: mxg300271. Customer has not returned the device to the manufacturer for device evaluation. If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10


[75871184] It was reported that a medex? Kids kit? Closed blood sampling system had broken tubing at the site of the syringe. No injury was reported. See mfr: 3012307300-2017-01157.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2017-01069
MDR Report Key6588258
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2017-05-24
Date of Report2017-05-24
Date Mfgr Received2017-05-01
Date Added to Maude2017-05-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactJENNIFER MENG
Manufacturer Street6000 NATHAN LANE NORTH
Manufacturer CityMINNEAPOLIS MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer Phone7633833078
Manufacturer G1SMITHS HEALTHCARE MANUFACTURING SA DE CV
Manufacturer StreetCARRETERA MIGUEL ALEM PARQUE INDUSTRIAL MONTERREY
Manufacturer CityAPODACA, NL CP 66603
Manufacturer CountryMX
Manufacturer Postal CodeCP 66603
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 Received2017-05-24
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.
Manufacturer Address6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
10 2017-05-24

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