SYRINGE ORAL 5ML AMBER 305208

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-07 for SYRINGE ORAL 5ML AMBER 305208 manufactured by Becton Dickinson Medical Systems.

Event Text Entries

[144459294] Date of event: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10


[144459295] It was reported that the syringe oral 5ml amber the graduation markings on syringe rub off when touched. There were 10 occurrences. The following information was provided by the initial reporter: material no: 305208, batch no: 9009848. Description: "graduations on syringe fade when touched. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1213809-2019-00511
MDR Report Key8587096
Date Received2019-05-07
Date of Report2019-06-14
Date of Event2019-04-26
Date Mfgr Received2019-04-26
Device Manufacturer Date2019-01-09
Date Added to Maude2019-05-07
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 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 NameSYRINGE ORAL 5ML AMBER
Generic NameLIQUID MEDICATION DISPENSER
Product CodeKYW
Date Received2019-05-07
Catalog Number305208
Lot Number9009848
Device Availability*
Device AgeDA
Device Eval'ed by MfgrR
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 2019-05-07

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