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

Catalog Number	212526
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
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
It was reported prior to use that the label of bd bbl¿ gram crystal violet was missing on one carton.There was no health impact or consequences reported.
Additional Manufacturer Narrative
The following fields have been updated with additional information.D9: device available for evaluation: yes.D9: returned to manufacturer on: 26-nov-2024.Investigation summary: this memo is to summarize findings on your complaint related to bottle gram crystal violet 3.8l, catalog number 212526, batch 4067795, complaint # (b)(4) for a missing label.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 deviations.The label reconciliation form was also reviewed, and it was noted there was a (b)(4) deviation between the number of labels issued and the number of labels that remained.This percentage is within the allowable limits per the label accountability policy established in our procedure.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 issue for this batch#.A return was received on 05-20-2024.It consisted of a carton part# 624001jaa (06) labeled with dot flammable liquids and un1987 alcohols nos (methanol, ethanol).No carton label with the name, catalog#, and batch# information was visible.Inside the carton was a 3.8l container with a cap on and a packaged spout.The 3.8l container had the side label with the name of the product (crystal violet), catalog# (212526), and the batch# (4067795).There was also the small, top label containing the name of the product.Once the product is packaged and leaves our facility, bd has no control over what occurs during shipping and upon receipt of the customer.This complaint cannot be confirmed.Bd will continue to trend dcm complaints for this issue.If you have further questions, please contact technical services.
Event or Problem Description
It was reported prior to use that the label of bd bbl¿ gram crystal violet was missing on one carton.There was no health impact or consequences reported.

• Brand Name: BD BBL¿ GRAM CRYSTAL VIOLET
• 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: 19506858
• Report Number: 1119779-2024-00495
• Device Sequence Number: 19687662
• Product Code: JTS
• UDI-Device Identifier: 00382902125266
• UDI-Public: (01)00382902125266(11)240307(17)250831(10)4067795
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 12/04/2024

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: 08/31/2025
• Device Catalogue Number: 212526
• Device Lot Number: 4067795
• 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: 05/13/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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