JAMSHIDI BONE MARROW BIOPSY NEEDLE, 13G, 2" DJ2013X

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-02 for JAMSHIDI BONE MARROW BIOPSY NEEDLE, 13G, 2" DJ2013X manufactured by Carefusion, Inc.

Event Text Entries

[96480328] (b)(4). Follow up submission will be completed post investigation or if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10


[96480329] During incoming visual inspection at bd (b)(4)- (2 out of 100) packages were found to be unsealed, therefore sterility compromised.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9680904-2017-00228
MDR Report Key7159406
Date Received2018-01-02
Date of Report2018-02-27
Date of Event2017-11-30
Date Mfgr Received2017-12-13
Date Added to Maude2018-01-02
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 ANNA WEHRHEIM
Manufacturer Street75 N. FAIRVIEW DRIVE
Manufacturer CityVERNON HILLS IL 60061
Manufacturer CountryUS
Manufacturer Postal60061
Manufacturer G1CAREFUSION, INC
Manufacturer StreetZONA FRANCA LAS AMERICAS
Manufacturer CitySANTO DOMINGO
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameJAMSHIDI BONE MARROW BIOPSY NEEDLE, 13G, 2"
Generic NameBONE BIOPSY NEEDLE
Product CodeFSH
Date Received2018-01-02
Catalog NumberDJ2013X
Lot Number0001094783
Device Availability*
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION, INC
Manufacturer AddressZONA FRANCA LAS AMERICAS SANTO DOMINGO


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-01-02

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