SET, ADMIN, CADD, 130", EPID, SPIKE, 0.2 FLTR, YELLOW STRIPE 21-7339-24

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-31 for SET, ADMIN, CADD, 130", EPID, SPIKE, 0.2 FLTR, YELLOW STRIPE 21-7339-24 manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[185903937] Information was received indicating that a smiths medical administration set was implicated in a medication not being delivered to the patient. The patient was not getting comfortable. It was discovered that no medication was being delivered by viewing the medication contained despite the pump indicating medication was being delivered. There were no adverse events reported due to this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-02429
MDR Report Key9908426
Report SourceUSER FACILITY
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-01-31
Date Mfgr Received2020-03-02
Device Manufacturer Date2019-10-24
Date Added to Maude2020-03-31
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 ContactDAVE HALVERSON
Manufacturer Street6000 NATHAN LANE NORTH
Manufacturer CityMINNEAPOLIS, MN
Manufacturer CountryUS
Manufacturer Phone3833310
Manufacturer G1SMITHS MEDICAL ASD, INC.
Manufacturer Street6000 NATHAN LANE NORTH
Manufacturer CityMINNEAPOLIS, MN
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSET, ADMIN, CADD, 130", EPID, SPIKE, 0.2 FLTR, YELLOW STRIPE
Generic NameSET, ADMINISTRATION, INTRAVASCULAR
Product CodeFPA
Date Received2020-03-31
Returned To Mfg2020-03-24
Model Number21-7339-24
Lot Number3882432
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.
Manufacturer Address6000 NATHAN LANE NORTH MINNEAPOLIS, MN US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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