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 2018-10-23 for BD VACUTAINER? CPT? NH: ~130 IU FICOLL?: 2.0ML 362753 manufactured by Becton, Dickinson & Co..

Event Text Entries

[124794437] 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


[124794438] It was reported that bd vacutainer? Cpt? Nh: ~130 iu ficoll? : 2. 0ml exhibited poor barrier separation. No serious injury or medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1917413-2018-03631
MDR Report Key7994808
Date Received2018-10-23
Date of Report2018-11-16
Date of Event2018-10-01
Date Mfgr Received2018-10-02
Device Manufacturer Date2018-02-07
Date Added to Maude2018-10-23
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 Received2018-10-23
Catalog Number362753
Lot Number8038549
Device Expiration Date2019-02-28
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 2018-10-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.