JAMSHIDI BONE MARROW BIOPSY DJ4008X

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-31 for JAMSHIDI BONE MARROW BIOPSY DJ4008X manufactured by Carefusion, Inc.

Event Text Entries

[91301637] (b)(4). Follow up submission will be completed post investigation or if additional information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[91301638] Open packages were found during inspection conducted by bd (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9680904-2017-00219
MDR Report Key6990589
Date Received2017-10-31
Date of Report2017-11-01
Date of Event2017-10-12
Date Mfgr Received2017-10-12
Date Added to Maude2017-10-31
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 StreetZONA FRANCA LAS AMERICAS
Manufacturer CitySANTO DOMINGO
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
Generic NameBONE BIOPSY NEEDLE
Product CodeFSH
Date Received2017-10-31
Catalog NumberDJ4008X
Lot Number1012015
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 2017-10-31

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