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	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Report 3 of 3: it was reported while using bd bbl¿ tb decolorizer, nocardia stained as full acid fast on a patient sample.There was no health impact or consequences reported.
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.
Event or Problem Description
Report 3 of 3: it was reported while using bd bbl¿ tb decolorizer, nocardia stained as full acid fast on a patient sample.There was no health impact or consequences report.
Additional Manufacturer Narrative
Investigation summary: this memo is to summarize findings on your complaint related to bottle tb decolorizer 250 ml, catalog number 212517, batch number 4060381, and complaint number (b)(4) 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.Three photos were attached in lieu of return.All photos depict a different microscope view of acid-fast stain bacteria.Bd bbl¿ tb stain kits 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.From customer's response: ¿afb qc slides were used and produced expected results.Positive control slide had pink/red acid-fast bacilli.Negative control slide had greenish-blue background¿.The organism described in the complaint report is nocardia.Bd does not have established release requirements or performance data for staining nocardia.Based on the limitations of the procedure and release specifications for the product, we are unable to further replicate the customer¿s application with this product.This complaint cannot be confirmed.Bd will continue to trend on performance issues.

• 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: 21098694
• Report Number: 1119779-2024-01062
• Device Sequence Number: 8665100
• Product Code: LED
• UDI-Device Identifier: 30382902125175
• UDI-Public: (01)30382902125175(11)240229(17)250228(10)4060381
• 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): 02/27/2025

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: 02/28/2025
• Device Catalogue Number: 212517
• Device Lot Number: 4060381
• 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: 12/10/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2024
• 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