MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ ACRIDINE ORANGE STAIN

Model Number	212537
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	01/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.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 when using bd bbl¿ acridine orange stain has performance issues the following information was provide the initial reporter: rapid test for presence of microorganisms (bacteria, yeast, mold) limitations of method multiple studies mentioned acridine orange¿s inability to discriminate between a live and dead cell.Saw poor correlation between this method and ingredients where there was a high level of non-viable bacteria due to a process step (e.G.Blanching of vegetables).
Additional Manufacturer Narrative
H.6 investigation summary: this memo is to summarize findings on your complaint related to bottle acridine orange stain 250ml 4 ea, catalog number 212537, and complaint #(b)(6) for issues differentiating bacteria.Components are milled and blended (where required) 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.Complaint investigation typically involves a review of the complaint batch history record.No complaint lot of material 212537 was provided, therefore no batch history review could be performed.Release testing for this product includes solution appearance, and cultural response with organisms as specified on the bd certificate of analysis.All qc results must meet the coa specifications prior to release.Complaint trends were reviewed for a period covering 12 months.During that time, there have been no complaints on this product for any reason.No photos or returns were received.This complaint is not confirmed.H3 other text : see h.10.
Event or Problem Description
It was reported when using bd bbl¿ acridine orange stain has performance issues.The following information was provide the intial reporter: rapid test for presence of microorganisms (bacteria, yeast, mold) limitations of method multiple studies mentioned acridine orange¿s inability to discriminate between a live and dead cell.Saw poor correlation between this method and ingredients where there was a high level of non-viable bacteria due to a process step (e.G.Blanching of vegetables).

• Brand Name: BD BBL¿ ACRIDINE ORANGE STAIN
• Common Device Name: ACRIDINE ORANGE
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16434405
• Report Number: 1119779-2023-00175
• Device Sequence Number: 3126897
• Product Code: IDC
• UDI-Device Identifier: 00382902125372
• UDI-Public: (01)00382902125372
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

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 Model Number: 212537
• Device Catalogue Number: 212537
• Device Lot Number: UNKNOWN
• 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: 01/23/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 04/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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