MEDIPLAST C-FLO DECANTER 2000S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-10 for MEDIPLAST C-FLO DECANTER 2000S manufactured by Microtek Medical Inc..

Event Text Entries

[178756167] When opening item to prepare for use, the tip broke on two consecutive items. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092916
MDR Report Key9694373
Date Received2020-02-10
Date of Report2020-02-06
Date of Event2020-02-05
Date Added to Maude2020-02-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMEDIPLAST C-FLO DECANTER
Generic NameBAG DECANTER - CONTAINER, I.V
Product CodeKPE
Date Received2020-02-10
Model Number2000S
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMICROTEK MEDICAL INC.
Manufacturer AddressCOLUMBUS MS 39702 US 39702


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-10

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