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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 12/06/2021
Event Type  malfunction  
Event Description
It was reported that while testing with bd bactec¿ plus aerobic/f culture vials (plastic), a false positive result was obtained.Confirmatory gram and subculture testing was performed, and the result was negative.There was no report of patient impact.The following information was provided by the initial reporter: reported false positive.
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
Investigation summary: customer reported a false positive defect.Bd was unable to reproduce customer experience with the bactec product.A false positive response was not observed when retention samples were tested.Batch history records were reviewed, and all testing were within specification for product release.A complaint history review was conducted and only the current complaint was found relating to the incident lot number and the ¿as reported¿ defect code.Users are cautioned in the package insert under limitation of the procedure: ¿a gram-stained smear from culture medium may contain small number of non-viable organisms derived from media constituents, staining reagents, immersion oil, glass slide and specimens used for inoculation.There are many factors that can influence the false positive rate, including blood volume, blood cell counts, environmental factors, and media lot to lot variations.Complaint is unconfirmed based on retention samples and batch history record review.No correctives actions were required.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigation process.Plot/log file review: there were three plots, which all showed noisy signal.This signal noise can be caused by physical / environmental / electrical disruptions or events.H3 other text : see h10.
 
Event Description
It was reported that while testing with bd bactec¿ plus aerobic/f culture vials (plastic), a false positive result was obtained.Confirmatory gram and subculture testing was performed, and the result was negative.There was no report of patient impact.The following information was provided by the initial reporter: reported false positive.
 
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Brand Name
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
Type of Device
SYSTEM, 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 Key13119284
MDR Text Key288875269
Report Number2647876-2021-00381
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 02/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2022
Device Model Number442023
Device Catalogue Number442023
Device Lot Number1230633
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/06/2021
Initial Date FDA Received12/30/2021
Supplement Dates Manufacturer Received02/01/2022
Supplement Dates FDA Received02/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/18/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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