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

Model Number	212518
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The following is intended to summarize the investigation for customer complaint (b)(4), material 212518, lot 0237774 for precipitate.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 kf.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 confirmed complaints for the defect in question.Two photos were received.The first photo depicts a view of a bottle of tb carbolfuchsin kf fert # 212518, exp 2021-09-30.The lot number covered by hand holding the bottle.The second photo depicts a bottle of tb carbolfuchsin kf lot # 0237774.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 reddish purple suspension with no visible precipitate, impurities or contamination.Staining was completed per instructions in the product insert.Slides of positive (m.Tuberculosis atcc 25177) and negative (b.Subtilis atcc 6533) controls were evaluated and gave satisfactory staining results with the retention and control batches.The retention was comparable to the control.This complaint cannot be confirmed.
Event or Problem Description
It was reported that while using bd bbl¿ tb carbolfuchsin kf contamination precipitate was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact."impurity.On 21mar2021/(b)(4).Update from rcc provided: there is no contamination.Yes, it is precipitate in the stain.User found the purple particle after looking at the microscope.".

• Brand Name: BD BBL TB CARBOLFUCHSIN KF
• Common Device Name: CARBOL FUCHSIN
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11653760
• Report Number: 1119779-2021-00657
• Device Sequence Number: 17030826
• Product Code: ICL
• UDI-Device Identifier: 00382902125181
• UDI-Public: 00382902125181
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2021

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: 09/30/2021
• Device Model Number: 212518
• Device Catalogue Number: 212518
• Device Lot Number: 0237774
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1