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

Model Number 212518

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: 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 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.One photo was received.The photo depicts a microscopic view of a stain slide.A mixture of purple and blue green stain can be seen.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 is not confirmed.

Event Description

It was reported that while using bd bbl¿ tb carbolfuchsin kf contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "impurities".

• Brand Name: BD BBL TB CARBOLFUCHSIN KF
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12028646
• MDR Text Key: 269604032
• Report Number: 1119779-2021-01010
• Device Sequence Number: 1
• Product Code: ICL
• UDI-Device Identifier: 00382902125181
• UDI-Public: 00382902125181
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/01/2021

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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2021
• Initial Date FDA Received: 06/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2020
• 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