BD INSULIN SYRINGE WITH THE BD ULTRA-FINE? NEEDLE 0.5 ML 328447

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-02-18 for BD INSULIN SYRINGE WITH THE BD ULTRA-FINE? NEEDLE 0.5 ML 328447 manufactured by Bd Medical - Diabetes Care.

Event Text Entries

[184497438] Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10


[184497439] It was reported that bd insulin syringe with the bd ultra-fine? Needle 0. 5 ml was damaged. This was discovered during use. The following information was provided by the initial reporter: material no: 328447 batch no: 9231522. It was reported that the chamber where insulin is held once it is drawn into vial is broken (inside syringe is exposed). Verbatim: chamber where insulin is held once it is drawn into vial is broken (inside syringe is exposed). Rn who reported this product defect mentioned that this is how the syringe came in the package. There was no shares of plastic in the packaging.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1920898-2020-00141
MDR Report Key9720226
Report SourceCONSUMER,OTHER
Date Received2020-02-18
Date of Report2020-03-04
Date of Event2020-01-29
Date Mfgr Received2020-01-29
Device Manufacturer Date2019-08-19
Date Added to Maude2020-02-18
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 NameBD INSULIN SYRINGE WITH THE BD ULTRA-FINE? NEEDLE 0.5 ML
Generic NameSYRINGE, ANTISTICK
Product CodeMEG
Date Received2020-02-18
Catalog Number328447
Lot Number9231522
OperatorLAY USER/PATIENT
Device Availability*
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 2020-02-18

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