MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ TB FLUORESCENT STAIN KIT T; STAINS, MICROBIOLOGIC

Catalog Number	212521
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).Initial reporter last name: (b)(6).H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd bbl tb fluorescent stain kit t there was presence of precipitate.No patient impact was reported.The following information was provided by the initial reporter: during the last 2 supervisions by the south-east metropolitan service (years 2022 and 2023), in conjunction with the peec reports, observations have been made regarding the presence of precipitates in our bacilloscopies.The occurrence of said interferent varies from rare to regular.
Event or Problem Description
It was reported that bd bbl¿ tb fluorescent stain kit t there was presence of precipitate.This event occurred twenty-two (22) times.No patient impact was reported.The following information was provided by the initial reporter: during the last 2 supervisions by the south-east metropolitan service (years 2022 and 2023), in conjunction with the peec reports, observations have been made regarding the presence of precipitates in our bacilloscopies.The occurrence of said interferent varies from rare to regular.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: b.5.Describe event or problem: it was reported that bd bbl¿ tb fluorescent stain kit t there was presence of precipitate.This event occurred twenty-two (22) times.No patient impact was reported.The following information was provided by the initial reporter: during the last 2 supervisions by the south-east metropolitan service (years 2022 and 2023), in conjunction with the peec reports, observations have been made regarding the presence of precipitates in our bacilloscopies.The occurrence of said interferent varies from rare to regular.D.4.Medical device lot #: 3010815.D.4.Medical device expiration date: 31-dec-2023.H.4.Device manufacture date: 10-jan-2023.H.6.Investigation summary: the following summary is in response to complaint (b)(4) submitted against material 212521, lot 3010815.Components are mixed and dispensed into the appropriate containers.After qc testing product is released and transported to the distribution center.The complaint investigation included a review of the batch history record for tb fluorescent stain kit t.The batch history record reviews indicated no discrepancies.All release testing was satisfactory.Complaint trends were reviewed for a period covering 12 months.During that time there have been no confirmed complaints for the defect in question.No returns or photos were received.A retention sample from the complaint batch number 3010815 was evaluated along with a control batch.Staining was completed per instructions in the product insert.Slides of positive (m.Tuberculosis atcc 25177) and negative (b.Subtilis atcc 6533) controls were evaluated and gave satisfactory staining results with the retention and control batches.The retention was comparable to the control.This complaint is not confirmed.
Additional Manufacturer Narrative
The following fields have been updated: b5.It was reported that an unknown number of bd bbl¿ tb fluorescent stain kit t were contaminated.There was no report of patient impact.This supplemental mdr is being submitted as part of a retrospective review of records dating (b)(6) 2023¿2025, under capa 11910483.
Event or Problem Description
It was reported that an unknown number of bd bbl¿ tb fluorescent stain kit t were contaminated.There was no report of patient impact.

• Brand Name: BD BBL¿ TB FLUORESCENT STAIN KIT T
• Common Device Name: STAINS, MICROBIOLOGIC
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17561206
• Report Number: 1119779-2023-00900
• Device Sequence Number: 15124452
• Product Code: JTS
• UDI-Device Identifier: 00382902125211
• UDI-Public: 00382902125211
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2025

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: 12/31/2023
• Device Catalogue Number: 212521
• Device Lot Number: 3010815
• 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: 08/04/2023
• Supplement Date Received by Manufacturer: 12/21/2023; 08/20/2025
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 01/17/2024; 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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