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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ MGIT¿ 960 SYSTEM; SYSTEM, BLOOD CULTURING
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BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ MGIT¿ 960 SYSTEM; SYSTEM, BLOOD CULTURING Back to Search Results
Model Number 445870
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/08/2022
Event Type  malfunction  
Event Description
It was reported that while using bd bactec¿ mgit¿ 960 system there were problems with antibiograms.No patient impact reported.The following information was provided by the initial reporter: problems with antibiograms.
 
Manufacturer Narrative
Medical device expiration date: na.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.
 
Event Description
It was reported that while using bd bactec¿ mgit¿ 960 system there were problems with antibiograms.No patient impact reported.The following information was provided by the initial reporter: problems with antibiograms.
 
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Brand Name
BD BACTEC¿ MGIT¿ 960 SYSTEM
Type of Device
SYSTEM, BLOOD CULTURING
Manufacturer (Section D)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
Manufacturer (Section G)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15298942
MDR Text Key305264615
Report Number1119779-2022-01141
Device Sequence Number1
Product Code MDB
UDI-Device Identifier00382904458706
UDI-Public00382904458706
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K974883
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number445870
Device Catalogue Number445870
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/27/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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