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

Model Number	261181
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem 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.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted mfr report was sent in error.The issue was a qc failure therefore, this is not considered to be a reportable malfunction.
Event or Problem 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.

• Brand Name: BD BBL; OXIDASE REAGENT DROPPER
• Common Device Name: DISCS, STRIPS & REAGENTS, MICROORGANISM DIFFERENTIATION
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11406499
• Report Number: 1119779-2021-00420
• Device Sequence Number: 3791557
• Product Code: JTO
• UDI-Device Identifier: 30382902611814
• UDI-Public: 30382902611814
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2021

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
• Operator of Device: Other
• Device Expiration Date: 07/30/2021
• Device Model Number: 261181
• Device Catalogue Number: 261181
• Device Lot Number: B01B211M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 09/25/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1