BD? ORAL DISPENSING SYRINGE 3 ML 305220

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-12 for BD? ORAL DISPENSING SYRINGE 3 ML 305220 manufactured by Becton Dickinson Medical Systems.

Event Text Entries

[130324763] 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


[130324764] It was reported that bags for the bd? Oral dispensing syringe 3 ml had no lot number identification on them.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1213809-2018-00900
MDR Report Key8156205
Date Received2018-12-12
Date of Report2018-12-10
Date of Event2018-11-08
Date Mfgr Received2018-11-27
Date Added to Maude2018-12-12
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 Phone8015652845
Manufacturer G1BECTON DICKINSON MEDICAL SYSTEMS
Manufacturer StreetROUTE 7 AND GRACE WAY
Manufacturer CityCANAAN CT 06018
Manufacturer CountryUS
Manufacturer Postal Code06018
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBD? ORAL DISPENSING SYRINGE 3 ML
Generic NameORAL SYRINGE
Product CodeKYW
Date Received2018-12-12
Catalog Number305220
Lot NumberUNKNOWN
Device Availability*
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBECTON DICKINSON MEDICAL SYSTEMS
Manufacturer AddressROUTE 7 AND GRACE WAY CANAAN CT 06018 US 06018


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-12-12

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