JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP BAK4511

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-09-28 for JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP BAK4511 manufactured by Carefusion, Inc.

Event Text Entries

[55822288] (b)(4) initial emdr submission. A follow up emdr will be submitted upon completion of investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[55822289] Sales rep stated via email: the user was trying to get a sample out of the jamshidi needle and stuck her thumb with the needle (on 2 different dates). Additional information received 15sept2016: as i was not directly involved, this is what was reported to me. First incident was approx. 1st wk of (b)(6). Dr. (b)(6) performed bone marrow procedure. Was having difficulty removing sample fm coring needle. Was really jammed in. Was pushing for approx. 10 mins and could not get it to budge. Passed it off to his ma who continued to work with it and in the process she somehow nicked/scraped herself w/bone marrow needle. Was successful in getting core sample out and didn't even realize she had scraped herself until she went to wash hands, felt sting, and did close inspection. So this did not occur during actual pt procedure which was completed, there was no pt involvement. Of note both times protocol was followed and ma went to hr for health screening follow up. Ma was interviewed regarding bone marrow policy and procedure w/emphasis on safety. Second needle stick is captured in (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[60679840] (b)(4) follow up emdr for device evaluation. With no sample or picture to evaluate, the investigation was unable to confirm this failure mode. The dhr was reviewed and no anomalies were found during the date of production; therefore this complaint could not be confirmed. The most probable root cause of the reported complaint is product misuse, the dhr did not show any manufacturing related defects and the trend report did not reveal any adverse trends. The dhr was reviewed and no anomalies were found during the date of production; therefore this complaint could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1625685-2016-00253
MDR Report Key5983269
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2016-09-28
Date of Report2016-11-22
Date of Event2016-08-04
Date Mfgr Received2016-09-14
Date Added to Maude2016-09-28
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 ContactANNA WEHRHEIM
Manufacturer Street75 NORTH FAIRWAY DRIVE
Manufacturer CityVERNON HILLS IL 60061
Manufacturer CountryUS
Manufacturer Postal60061
Manufacturer Phone8473628063
Manufacturer G1CAREFUSION, INC
Manufacturer Street400 EAST FOSTER RD
Manufacturer CityMANNFORD OK 74044
Manufacturer CountryUS
Manufacturer Postal Code74044
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameJAMSHIDI BONE MARROW TRAY 11G X4 15G ASP
Generic NameTRAY, SURGICAL, NEEDLE
Product CodeFSH
Date Received2016-09-28
Model NumberBAK4511
Lot Number0000922436
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION, INC
Manufacturer Address75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-09-28

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