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

Model Number 261181

Device Problem Incorrect, Inadequate or Imprecise Result or 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.

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 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
• Type of Device: DISCS, STRIPS & REAGENTS, MICROORGANISM DIFFERENTIATION
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11406499
• MDR Text Key: 246061987
• Report Number: 1119779-2021-00420
• Device Sequence Number: 1
• Product Code: JTO
• UDI-Device Identifier: 30382902611814
• UDI-Public: 30382902611814
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 09/25/2021
• Supplement Dates FDA Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1