BD VACUTAINER? C&S BORIC ACID KIT SODIUM BORATE/FORMATE 364944

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-14 for BD VACUTAINER? C&S BORIC ACID KIT SODIUM BORATE/FORMATE 364944 manufactured by Becton, Dickinson & Co..

Event Text Entries

[117268011] There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 7333954, medical device expiration date: 2019-06-30, device manufacture date: 2017-11-29. Medical device lot #: 7333955, medical device expiration date: 2019-06-30, device manufacture date: 2017-11-29. (b)(6). 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


[117268012] It was reported with the use of the bd vacutainer? C&s boric acid kit sodium borate/formate there was an issue with closure separation. There was no report of injury or further medical intervention.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1917413-2018-03295
MDR Report Key7783096
Date Received2018-08-14
Date of Report2018-09-26
Date of Event2018-07-30
Date Mfgr Received2018-07-30
Date Added to Maude2018-08-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 & CO.
Manufacturer Street150 SOUTH 1ST AVENUE
Manufacturer CityBROKEN BOW NE 68822
Manufacturer CountryUS
Manufacturer Postal Code68822
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBD VACUTAINER? C&S BORIC ACID KIT SODIUM BORATE/FORMATE
Generic NameTRANSPORT CULTURE MEDIUM
Product CodeLIO
Date Received2018-08-14
Catalog Number364944
Lot NumberSEE H.10
Device Availability*
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBECTON, DICKINSON & CO.
Manufacturer Address150 SOUTH 1ST AVENUE BROKEN BOW NE 68822 US 68822


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-08-14

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