BD VACUTAINER? CPT? NH: ~130 IU FICOLL?: 2.0ML 362753

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-27 for BD VACUTAINER? CPT? NH: ~130 IU FICOLL?: 2.0ML 362753 manufactured by Becton, Dickinson & Co..

Event Text Entries

[118529476] Date of event: unknown. 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


[118529477] It was reported that a bd vacutainer? Cpt? Nh: ~130 iu ficoll? : 2. 0ml had gel separation. There was no report of exposure, serious injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1917413-2018-03335
MDR Report Key7820020
Date Received2018-08-27
Date of Report2018-10-12
Date of Event2018-08-07
Date Mfgr Received2018-08-07
Device Manufacturer Date2017-09-29
Date Added to Maude2018-08-27
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? NH: ~130 IU FICOLL?: 2.0ML
Generic NameBLOOD SPECIMEN COLLECTION DEVICE
Product CodeJCF
Date Received2018-08-27
Returned To Mfg2018-08-20
Catalog Number362753
Lot Number7272765
Device Expiration Date2018-10-31
Device AvailabilityR
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 2018-08-27

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