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	08/23/2024
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 using bd bbl¿ gram stain kit that a component was missing a 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 a component was missing a product label.There was no health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary this memo is to summarize findings on your 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 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 and no photos were received.The complaint does not specify which label was missing and from where the leaking was coming.Without this information no further investigation can be performed.Once the product leaves our facility, bd has no control over what occurs during shipping by third parties and/or receipt by the customer.This complaint cannot be 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20770743
• Report Number: 1119779-2024-00924
• Device Sequence Number: 8004955
• 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: TX
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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: 11/07/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 02/10/2025
• 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