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

Catalog Number	212539
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
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 prior to using bd bbl gram stain kit that one (1) safranin red bottle was missing the product label.There was no health impact or consequence reported.
Event or Problem Description
It was reported prior to using bd bbl gram stain kit that one (1) safranin red bottle was missing the product label.There was no health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary - this memo is to summarize findings on the complaint related to kit gram stain stabilized, catalog number 212539, batch# 4100083, and complaint #(b)(4) for missing label and leakage.Components are mixed 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.The complaint investigation included a review of the batch history record.The batch history record review indicated no discrepancies.All release testing was satisfactory.The packaging documentation was reviewed for this batch.There were no anomalies noted during the packaging event.All torque and label checks completed throughout the packaging run were satisfactory.The complaint trends were reviewed for a period covering 12 months.During that time there have been no other confirmed complaints for these issues.No return was received, but two photos were received.Photo number 1 depicted a bottle with a dark rose-colored liquid that contained two long smears from the beginning of the body of the bottle to the bottom of the bottle.There were no smears evident on the neck of the bottle.No label was visible on the bottle and the top of the bottle was not shown.The second photo depicted presumably the same bottle as shown in photo 1 due to the similarity of the smears on the bottle.This photo showed the bottle in full length, including the shipping cap on top.Again, no label was visible.The shipping cap showed no staining and, again there were no stains on the neck of the bottle.The bottle was placed in front of a kit tray which was in the shipping bag.The kit tray contained a bottle each of gram crystal violet (label visible, but batch# not visible), gram iodine (label visible, batch# 4053253), and gram decolorizer (label visible, batch# not visible).The bagged kit tray was in turn in front of the shipping box with the catalog#212539 visible.There were no signs of stains on the bag, the other bottles, or the kit tray.The bottle not showing a label resembled gram safranin catalog#212531 and based upon the complaint record batch#4053233 was the only gram safranin batch in gram stain kit, catalog#212539, batch#4100083.The batch history record for gram safranin was also reviewed and indicated no discrepancies.There were also no anomalies noted during its¿ packaging event and all torque and label checks completed throughout its¿ packaging run were satisfactory as well.This complaint is confirmed.Bd will continue to trend on packaging issues.

• 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: 20345357
• Report Number: 1119779-2024-00710
• Device Sequence Number: 7945451
• Product Code: JTS
• UDI-Device Identifier: 00382902125396
• UDI-Public: (01)00382902125396(11)240409(17)250731(10)4100083
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/13/2025

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: 07/31/2025
• Device Catalogue Number: 212539
• Device Lot Number: 4100083
• 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: 09/03/2024
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2024
• 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