SYRINGE 0.5ML 30GA TW 8MM BLS 400 SG 305934

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-03-18 for SYRINGE 0.5ML 30GA TW 8MM BLS 400 SG 305934 manufactured by Bd Medical - Diabetes Care.

MAUDE Entry Details

Report Number1920898-2020-00274
MDR Report Key9850350
Report SourceFOREIGN,OTHER,USER FACILITY
Date Received2020-03-18
Date of Report2020-03-26
Date of Event2020-02-27
Date Mfgr Received2020-02-27
Device Manufacturer Date2018-07-30
Date Added to Maude2020-03-18
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 - DIABETES CARE
Manufacturer Street1329 WEST HIGHWAY 6
Manufacturer CityHOLDREGE NE 68949
Manufacturer CountryUS
Manufacturer Postal Code68949
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSYRINGE 0.5ML 30GA TW 8MM BLS 400 SG
Generic NameSYRINGE, ANTISTICK
Product CodeMEG
Date Received2020-03-18
Catalog Number305934
Lot Number8211636
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBD MEDICAL - DIABETES CARE
Manufacturer Address1329 WEST HIGHWAY 6 HOLDREGE NE 68949 US 68949


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-18

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