SYRINGE 5ML HEPARIN 10 UNIT 306414

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-15 for SYRINGE 5ML HEPARIN 10 UNIT 306414 manufactured by Bd Medical (bd West) Medical Surgical.

MAUDE Entry Details

Report Number1911916-2019-01089
MDR Report Key9191928
Date Received2019-10-15
Date of Report2019-11-18
Date of Event2019-01-01
Date Mfgr Received2019-09-30
Date Added to Maude2019-10-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 Phone8015652341
Manufacturer G1BD MEDICAL (BD WEST) MEDICAL SURGICAL
Manufacturer Street1852 10TH AVENUE
Manufacturer CityCOLUMBUS NE 68601
Manufacturer CountryUS
Manufacturer Postal Code68601
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSYRINGE 5ML HEPARIN 10 UNIT
Generic NameHEPARIN, VASCULAR ACCESS FLUSH
Product CodeNZW
Date Received2019-10-15
Catalog Number306414
Lot NumberUNKNOWN
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBD MEDICAL (BD WEST) MEDICAL SURGICAL
Manufacturer Address1852 10TH AVENUE COLUMBUS NE 68601 US 68601


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-10-15

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