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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ MGIT¿ 320 SYSTEM SYSTEM, BLOOD CULTURING

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BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ MGIT¿ 320 SYSTEM SYSTEM, BLOOD CULTURING Back to Search Results
Model Number 441743
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/11/2022
Event Type  malfunction  
Manufacturer Narrative
Device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported by the customer that they are facing intermittent wrong results on bd bactec¿ mgit¿ 320 system. There was one occurrence in this event with no patient impact. The following information was provided by the customer: "customers faces intermittent wrong results".
 
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Brand NameBD BACTEC¿ MGIT¿ 320 SYSTEM
Type of DeviceSYSTEM, 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 Key15321964
MDR Text Key302119949
Report Number1119779-2022-01146
Device Sequence Number1
Product Code MDB
UDI-Device Identifier00382904417437
UDI-Public00382904417437
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K974883
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number441743
Device Catalogue Number441743
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/11/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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