MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ TB DECOLORIZER; STAINS, CHEMICAL SOLUTION

Catalog Number	212517
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	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd bbl¿ tb decolorizer, one (1) patient sample contained branching organisms that was staining kinyoun positive.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary - components are mixed and dispensed into containers.Following qc release, and based upon inventory demand, final packaging operations occur followed by transport to the distribution center.The complaint investigation included a review of the batch history record for tb decolorizer.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.Bd bbl¿ tb stain kits (tb decolorizer is one of the components) are used to manually stain smears prepared from specimens and cultures suspected of containing mycobacteria, especially mycobacterium tuberculosis, for qualitative early presumptive diagnosis of mycobacterial infection and characterization of bacterial isolates.Slides of positive (m.Tuberculosis atcc 25177) and negative (b.Subtilis atcc 6533) controls were evaluated and gave satisfactory staining results at release of the product.One photo was attached in lieu of return.The photo depicts a microscope view of bacteria rods stained red and blue-green colors.The only information given concerning the photo is that it is from a patient.From customer's response: ¿we used afb qc slides which gave expected results.¿ the customer was expecting to obtain modified acid stain positive results for their sample.Improper storage of the decolorizer can weaken it which can then lead to altered results for staining procedures.Light, heat and air can degrade the acid content or evaporate the alcohol content of the decolorizer essentially altering the acid fast stain into a modified acid fast stain.This complaint cannot be confirmed.Bd will continue to trend on performance issues.
Event or Problem Description
It was reported while using bd bbl¿ tb decolorizer, one (1) patient sample contained branching organisms that was staining kinyoun positive.No adverse impact was reported regarding the patient or user.

• Brand Name: BD BBL¿ TB DECOLORIZER
• Common Device Name: STAINS, CHEMICAL SOLUTION
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 21411153
• Report Number: 1119779-2025-00086
• Device Sequence Number: 18477858
• Product Code: LED
• UDI-Device Identifier: 30382902125175
• UDI-Public: (01)30382902125175(11)240409(17)250331(10)4100005
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 03/31/2025
• Device Catalogue Number: 212517
• Device Lot Number: 4100005
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2024
• 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