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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED SYSTEM, BLOOD CULTURING

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BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED SYSTEM, BLOOD CULTURING Back to Search Results
Catalog Number 441385
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/03/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used as a default. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Medical device expiration date: na.
 
Event Description
It was reported that while using bd bactec¿ fx, instrument top, packaged miss association was observed by the laboratory personnel. There was no indication that results were reported out and there was no report of patient impact. The following information was provided by the initial reporter: "software or equipment itself that could have hypothesized the probability of a false positive result given at some point by the operation or reading of the bd bactectm fx positivity and negativity algorithms during monitoring of the sample incubation. ".
 
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Brand NameBD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED
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 Key13120560
MDR Text Key288502009
Report Number1119779-2021-02065
Device Sequence Number1
Product Code MDB
UDI-Device Identifier00382904413859
UDI-Public0382904413859
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K915796A
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 01/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number441385
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/10/2019
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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