BD VACUTAINER? CPT? CELL PREPARATION TUBE WITH SODIUM CITRATE 362761

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-07 for BD VACUTAINER? CPT? CELL PREPARATION TUBE WITH SODIUM CITRATE 362761 manufactured by Becton, Dickinson & Co..

Event Text Entries

[132348206] Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. (b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
Patient Sequence No: 1, Text Type: N, H10


[132348207] It was reported that there were thought to be "irregular amounts of sodium citrate" in the bd vacutainer? Cpt? Cell preparation tubes with sodium citrate that led to erroneous results.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1917413-2018-04111
MDR Report Key8224223
Date Received2019-01-07
Date of Report2019-02-13
Date of Event2018-12-18
Date Mfgr Received2018-12-18
Date Added to Maude2019-01-07
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 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? CPT? CELL PREPARATION TUBE WITH SODIUM CITRATE
Generic NameLYMPHOCYTE SEPARATION MEDIUM
Product CodeJCF
Date Received2019-01-07
Catalog Number362761
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by MfgrR
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 2019-01-07

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