MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ UREASE TEST BROTH; SEE H.10

Model Number	221719
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	03/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.3 common device name: culture media, non-selective and differential.H.3.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 that while using the bd bbl¿ urease test broth that there was a performance issue.The following information was provided by the initial reporter: customer problem: customer reported lot#: 3039044 showing no reaction at all when inoculated with proteus sp.Customer reports in the past they used to order the 10x concentration tubes (221098), but since they discontinued the product, they got product 221719 as an alternative.Customer reports they have at least received one previous lot of 221719 before nd it reacted normally, however when they changed to lot#: 3039044 , they have not gotten any reaction on any of the tubes.If consumable is tested on bd instrumentation, list serial numbers: lot#: 3039044.Hazard, injury or erroneous results? yes.Hazard, injury or erroneous results details no reaction.
Event or Problem Description
It was reported that while using the bd bbl¿ urease test broth that there was a performance issue.The following information was provided by the initial reporter: customer problem: customer reported lot#: 3039044 showing no reaction at all when inoculated with proteus sp.Customer reports in the past they used to order the 10x concentration tubes (221098), but since they discontinued the product, they got product 221719 as an alternative.Customer reports they have at least received one previous lot of 221719 before nd it reacted normally, however when they changed to lot#: 3039044 , they have not gotten any reaction on any of the tubes.If consumable is tested on bd instrumentation, list serial numbers: lot#: (b)(6).Hazard, injury or erroneous results? yes; hazard, injury or erroneous results details no reaction.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 1119779-2023-00468 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.H3 other text : see h.10.

• Brand Name: BD BBL¿ UREASE TEST BROTH
• Common Device Name: SEE H.10
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16801217
• Report Number: 1119779-2023-00468
• Device Sequence Number: 3063815
• Product Code: JSH
• UDI-Device Identifier: 30382902217191
• UDI-Public: 30382902217191
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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: 02/09/2024
• Device Model Number: 221719
• Device Catalogue Number: 221719
• Device Lot Number: 3039044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown