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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING

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BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING Back to Search Results
Model Number 442020
Device Problem False Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/06/2022
Event Type  malfunction  
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Brand NameBD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)
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 Key15291219
Report Number1119779-2022-01137
Device Sequence Number1
Product Code MDB
UDI-Device Identifier00382904420208
UDI-Public00382904420208
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151866
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/09/2022
1 Device was Involved in the Event
0 Patients were 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
Device Model Number442020
Device Catalogue Number442020
Device Lot Number1294782
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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