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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 AND REAGENTS, MICROORGANISM DIFFERENTIATION

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BECTON, DICKINSON & CO. (SPARKS) BD BBL OXIDASE REAGENT DROPPER DISCS, STRIPS AND 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 09/28/2021
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 using bd bbl¿ oxidase reagent dropper there was no reaction. False results were confirmed using known qc organisms that should have a reaction. There was no report of patient impact. The following information was provided by the initial reporter: it was reported that 261181 lot: b01c254m has no reaction. Customer reports the organisms she is an obvious clinical specimen that is pseudomonas aeruginosa. However the oxidase reaction is negative. No blue color change whatsoever. Customer waited a full minute and saw no color change at all.
 
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Brand NameBD BBL OXIDASE REAGENT DROPPER
Type of DeviceDISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
Manufacturer (Section D)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
MDR Report Key12693637
MDR Text Key282712470
Report Number1119779-2021-01712
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial
Report Date 10/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number261181
Device Catalogue Number261181
Device Lot NumberB01C254M
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2021
Is This a Reprocessed and Reused Single-Use Device? No

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