0.5ML 31GX6MM U-100 INSULIN SYRINGE 328520

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-03-19 for 0.5ML 31GX6MM U-100 INSULIN SYRINGE 328520 manufactured by Bd Medical - Diabetes Care.

MAUDE Entry Details

Report Number1920898-2020-00281
MDR Report Key9857377
Report SourceDISTRIBUTOR,OTHER
Date Received2020-03-19
Date of Report2020-03-27
Date of Event2020-02-27
Date Mfgr Received2020-02-28
Device Manufacturer Date2019-08-27
Date Added to Maude2020-03-19
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 Name0.5ML 31GX6MM U-100 INSULIN SYRINGE
Generic NamePISTON SYRINGE
Product CodeFMF
Date Received2020-03-19
Model Number328520
Catalog Number328520
Lot Number9203946
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
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 2020-03-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.