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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING

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BECTON DICKINSON CARIBE LTD. BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING Back to Search Results
Model Number 442023
Device Problem False Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/03/2021
Event Type  malfunction  
Manufacturer Narrative
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 that while testing with the bd bactec¿ plus aerobic/f culture vials (plastic), one false positive result was obtained. Confirmatory subculture testing was performed. Erroneous results were not reported out, and there was no report of patient impact. The following information was provided by the initial reporter: 1 false positive bottle on 442023 lot 1245128 due to poor sensor adhesion.
 
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Brand NameBD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
Type of DeviceSYSTEM, BLOOD CULTURING
Manufacturer (Section D)
BECTON DICKINSON CARIBE LTD.
vicks drive
lot no. 6
cayey PR
Manufacturer (Section G)
BECTON DICKINSON CARIBE LTD.
vicks drive
lot no. 6
cayey PR
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13114399
MDR Text Key285493036
Report Number2647876-2021-00380
Device Sequence Number1
Product Code MDB
UDI-Device Identifier00382904420239
UDI-Public00382904420239
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113558
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2022
Device Model Number442023
Device Catalogue Number442023
Device Lot Number1245128
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/02/2021
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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