CADD 100 ML MEDICATION CASSETTE RESERVOIR 21-7302-24

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-31 for CADD 100 ML MEDICATION CASSETTE RESERVOIR 21-7302-24 manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[185903058] Information was received indicating that a smiths medical cassette had a fold in the bladder of the cassette which would cause multiple air bubbles that could not be dispelled during the reconstitution process and that there were multiple air bubbles that despite manipulation with a syringe, the air bubbles were caught in the edge of the bladder. There were no adverse events reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-02506
MDR Report Key9908431
Report SourceDISTRIBUTOR
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2020-03-04
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 NameCADD 100 ML MEDICATION CASSETTE RESERVOIR
Generic NameSET, ADMINISTRATION, INTRAVASCULAR
Product CodeFPA
Date Received2020-03-31
Model Number21-7302-24
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.
Manufacturer Address6000 NATHAN LANE NORTH MINNEAPOLIS, MN US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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