BD?? ORAL SYRINGE WITH TIP CAP 305210

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-21 for BD?? ORAL SYRINGE WITH TIP CAP 305210 manufactured by Becton Dickinson Medical Systems.

Event Text Entries

[131313021] Date of event: unknown. The date received by manufacturer has been used for this field. Multiple lot numbers: there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 8236735. Medical device expiration date: n/a. Device manufacture date: 2018-08-24. Medical device lot #: 8236730. Medical device expiration date: n/a. Device manufacture date: 2018-08-24. (b)(6). 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


[131313022] It was reported that bd? Oral syringe with tip cap gave erroneous results. No serious injury or medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1213809-2018-00962
MDR Report Key8190286
Date Received2018-12-21
Date of Report2019-01-11
Date of Event2018-12-06
Date Mfgr Received2018-12-06
Date Added to Maude2018-12-21
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 SYRINGE WITH TIP CAP
Generic NameLIQUID MEDICATION DISPENSER
Product CodeKYW
Date Received2018-12-21
Catalog Number305210
Lot NumberSEE H.10
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 2018-12-21

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