BD CORNWALL? DISPOSABLE SYRINGE FILLING SYSTEM W/TUBING SET 305224

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-10 for BD CORNWALL? DISPOSABLE SYRINGE FILLING SYSTEM W/TUBING SET 305224 manufactured by Bd Infusion Therapy Systems Inc. S.a. De C.v..

Event Text Entries

[105395277] A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10


[105395278] It was reported that a bd cornwall? Disposable syringe filling system with tubing set was leaking at the vent port during use. There was no report of exposure, injury or medical interventions.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610847-2018-00082
MDR Report Key7411010
Date Received2018-04-10
Date of Report2018-05-10
Date of Event2018-03-21
Date Mfgr Received2018-03-21
Device Manufacturer Date2017-04-27
Date Added to Maude2018-04-10
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 ContactBDX BRETT WILKO
Manufacturer Street9450 SOUTH STATE STREET
Manufacturer CitySANDY UT 84070
Manufacturer CountryUS
Manufacturer Postal84070
Manufacturer Phone8015652845
Manufacturer G1BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
Manufacturer StreetPERIFERICO LUIS DONALDO COLOSIO NO. 579
Manufacturer CityNOGALES
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBD CORNWALL? DISPOSABLE SYRINGE FILLING SYSTEM W/TUBING SET
Generic NameSYRINGE
Product CodeKYX
Date Received2018-04-10
Returned To Mfg2018-04-04
Catalog Number305224
Lot Number7093584
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
Manufacturer AddressPERIFERICO LUIS DONALDO COLOSIO NO. 579 NOGALES US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-04-10

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