MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) NONE REPORTED.; STAINS, MICROBIOLOGIC

Catalog Number	212525
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	08/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 crystal violet that there was precipitate in the stain, which appeared to be gram positive cocci.One (1) patient had erroneous results of gram-positive cocci reported and was administered vancomycin.The result was subsequently corrected in the patient's chart.There was no further health impact or consequence reported.Reported verbatim, "hazard, injury or erroneous results? yes.Detailed erroneous results: falsely reported gram-positive cocci being seen on the gram stain slide.Was patient treatment changed in result of erroneous results: patient was treated with vancomycin.Customer is unsure at this moment if they will be changing treatment from the vancomycin".
Additional Manufacturer Narrative
Investigation summary: 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 batch history review of the gram crystal violet.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 this batch.No returns or photos were received.A retention sample from the complaint batch was evaluated along with a control batch of crystal violet.The solution appearance of retention sample was satisfactory and comparable to the control; all were deep purple solution with no visible precipitate.Slides of e.Coli atcc 25922 and s.Aureus atcc 25923 controls were evaluated and had satisfactory staining results for retention and control batches.Ten fields of each smear were examined in detail using oil immersion lens of a light microscope.No excessive precipitate, artifacts or bacterial contamination were seen.The retention sample was comparable to the control.This complaint is not confirmed.
Event or Problem Description
It was reported while using bd bbl¿ gram crystal violet that there was precipitate in the stain, which appeared to be gram positive cocci.One (1) patient had erroneous results of gram-positive cocci reported and was administered vancomycin.The result was subsequently corrected in the patient's chart.There was no further health impact or consequence reported.Reported verbatim, "hazard, injury or erroneous results? yes.Detailed erroneous results: falsely reported gram-positive cocci being seen on the gram stain slide.Was patient treatment changed in result of erroneous results: patient was treated with vancomycin.Customer is unsure at this moment if they will be changing treatment from the vancomycin".
Event or Problem Description
It was reported while using bd bbl¿ gram crystal violet that there was precipitate in the stain, which caused incorrect results for an unknown number of patients.There was no report of patient impact.
Additional Manufacturer Narrative
The following fields have been updated: b1.Adverse type: product problem b5.It was reported while using bd bbl¿ gram crystal violet that there was precipitate in the stain, which caused incorrect results for an unknown number of patients.There was no report of patient impact.H1.Type of reportable events: malfunction this supplemental mdr is being submitted as part of a retrospective review of records dating april 2023¿2025, under capa 11910483.

• Brand Name: NONE REPORTED.
• 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: 20432416
• Report Number: 1119779-2024-00751
• Device Sequence Number: 12888363
• Product Code: JTS
• UDI-Device Identifier: 30382902125250
• UDI-Public: (01)30382902125250(11)230925(17)250331(10)3268129
• 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,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/31/2025
• Device Catalogue Number: 212525
• Device Lot Number: 3268129
• 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: 09/23/2024
• Supplement Date Received by Manufacturer: 02/06/2025; 08/26/2025
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 03/05/2025; 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown