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

Model Number	212527
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
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 decolorizer complaint batch.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 other complaints received against this batch for any defect.Three photos were received in lieu of returns.All three photos depict a microscopic views of a gram stain slides showing various gram positive and gram negative organisms.A retention sample from the complaint batch was evaluated along with a control batch.The solution appearance was satisfactory and comparable to the control; both were a colorless, clear solution with no visible precipitate.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 with a retention and control batches.The retention sample was comparable to the control.Bd is unable to replicate the defect described by the customer.This complaint cannot be confirmed.Bd will continue to trend for dyes & stain performance defects.If you have further questions, please contact bd technical services.
Event or Problem Description
It was reported while using bd bbl¿ gram decolorizer the slides were overstripped.There was no report of patient impact.The following information was provided by the initial reporter: customer reported using gram stain kit for contamination checks of incoming micro samples as part of our standard process.During these checks i have run into a consistent issue with the gram decolorizer provided with your kit.My slides appear to always be over stripped of crystal violet.My procedure is as follows flood with crystal violet, allow to stand 1 minute, rinse thoroughly with di water, flood with gram iodine, allow to stand 1 minute, rinse thoroughly with di water, apply 1-2 drops of gram decolorizer, immediately rinse thoroughly with di water, flood slide with safranin, allow to stand 30 seconds, rinse thoroughly with di water.Dry in book of bibulous paper before microscopically observing results.I was wondering if there were any suggestions to prevent the over stripping of the crystal violet with the decolorizer? this has been a consistent problem even with control microbes such as b.Agri and b.Subtilis.

• Brand Name: BD BBL¿ GRAM 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14108002
• Report Number: 1119779-2022-00560
• Device Sequence Number: 11915404
• Product Code: LED
• UDI-Device Identifier: 00382902125273
• UDI-Public: 00382902125273
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2022

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: 05/31/2023
• Device Model Number: 212527
• Device Catalogue Number: 212527
• Device Lot Number: 1292815
• 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: 03/17/2022
• Initial Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2021
• 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