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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL; OXIDASE REAGENT DROPPER DISCS, STRIPS & REAGENTS, MICROORGANISM DIFFERENTIATION

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BECTON, DICKINSON & CO. (SPARKS) BD BBL; OXIDASE REAGENT DROPPER DISCS, STRIPS & REAGENTS, MICROORGANISM DIFFERENTIATION Back to Search Results
Model Number 261181
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/05/2021
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 while using bd bbl¿; oxidase reagent dropper there was negative results with p. Aeruginosa. The organisms were known oxidase positive. There were also weak reactions on campylobacter. Results were not reported and there was no impact to patient.
 
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Brand NameBD BBL; OXIDASE REAGENT DROPPER
Type of DeviceDISCS, STRIPS & REAGENTS, MICROORGANISM DIFFERENTIATION
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
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11406499
MDR Text Key246061987
Report Number1119779-2021-00420
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
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 09/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/30/2021
Device Model Number261181
Device Catalogue Number261181
Device Lot NumberB01B211M
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/14/2019
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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