MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ TB CARBOLFUCHSIN ZN; CARBOL FUCHSIN

Catalog Number 212511

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2023

Event Type  malfunction  

Event Description

It was reported that when using bd bbl¿ tb carbolfuchsin zn customer noticed precipitate in the stain.There was no report of impact to patient or user.

Manufacturer Narrative

H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: this memo is to summarize findings on your complaint related to bottle tb carbolfuchsin zn 250ml, catalog number 212511, batch 3150894, complaint #(b)(4) for unsatisfactory appearance.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 review of the batch history record for tb carbolfuchsin zn.The batch history record reviews 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 confirmed complaints for the defect in question.No photos or returns were received.The retention sample from the complaint batch was evaluated along with a control batch.The solution appearance for the retention sample was satisfactory and comparable to the control; all were a reddish-purple suspension with no visible precipitate, impurities, or contamination.Bd was unable to replicate the defect observed by the customer; consequently, this complaint cannot be confirmed.Bd will continue to trend dyes and stains product complaints for solution appearance defects.If you have further questions, please contact technical services.

Event Description

It was reported that when using bd bbl¿ tb carbolfuchsin zn customer noticed precipitate in the stain.There was no report of impact to patient or user.

• Brand Name: BD BBL¿ TB CARBOLFUCHSIN ZN
• Type of Device: CARBOL FUCHSIN
• 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: 18284994
• MDR Text Key: 330770167
• Report Number: 1119779-2023-01328
• Device Sequence Number: 1
• Product Code: ICL
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

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
• Device Operator: Other
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 212511
• Device Lot Number: 3150894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 01/16/2024
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1