PISTON IRRIGATION TRAY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-23 for PISTON IRRIGATION TRAY manufactured by C. R. Bard, Inc..

Event Text Entries

[184886667] The plunger on the irrigation syringe would not hold suction. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093899
MDR Report Key9871664
Date Received2020-03-23
Date of Report2020-03-20
Date Added to Maude2020-03-24
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 NamePISTON IRRIGATION TRAY
Generic NameSYRINGE, IRRIGATING (NON DENTAL)
Product CodeKYZ
Date Received2020-03-23
Lot NumberNGD2130
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerC. R. BARD, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-23

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