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

Catalog Number	212539
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	05/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.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 while using bd bbl gram stain kit that there was bacteria contamination on the quality control slide.The stain did not pass qualification for use and was not used on patient samples.
Event or Problem Description
It was reported while using bd bbl gram stain kit that there was bacteria contamination on the quality control slide.The stain did not pass qualification for use and was not used on patient samples.
Additional Manufacturer Narrative
The following fields have been updated with additional information.D9: device available for evaluation: yes d9: returned to manufacturer on: 31-may-2024 investigation summary: this memo is to summarize findings on your complaint related to kit gram stain stabilized, catalog number 212539, batch# 3297861, and complaint #10243613 for contamination.Components are mixed and dispensed into containers.Following qc release, and based upon inventory demand, final packaging operations occur, which include dispensing into and labeling of final configurations, followed by transport to the distribution center.The complaint investigation included a review of the gram stain kit.The batch history record review 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.The return was received on 31-may-2024.A retention and return samples from the complaint batch were evaluated along with a control batch.Staining was completed per instructions in the product insert.Slides of e.Coli atcc 25922 and s.Aureus atcc 25923 controls were evaluated and had satisfactory staining results for the retention, return and control batches.The retention and return samples were comparable to the control.Blank slides were stained with retention, return, and control batches.No contamination was found on any of the slides.Bd will continue to trend on this issue.

• Brand Name: BD BBL GRAM STAIN KIT
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19548472
• Report Number: 1119779-2024-00501
• Device Sequence Number: 4735028
• Product Code: JTS
• UDI-Device Identifier: 00382902125396
• UDI-Public: (01)00382902125396(11)231024(17)250228(10)3297861
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/13/2025

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: 212539
• Device Lot Number: 3297861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• 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