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

Model Number	212511
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2021
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 that while using bd bbl¿ tb carbolfuchsin zn dye and stain 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: "it was reported that the customer reported an increase amount of stain deposits on their slides when using the tb carbolfuchsin zn stain from lot 0237747, exp: 2021-09-30 (cat# 212511).".
Event or Problem Description
It was reported that while using bd bbl¿ tb carbolfuchsin zn dye and stain 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: "it was reported that the customer reported an increase amount of stain deposits on their slides when using the tb carbolfuchsin zn stain from lot 0237747, exp: 2021-09-30 (cat# 212511).".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-09-23.H6: 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 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.A customer return was received on 09/23/21.The return bottle of tb carbolfuchsin zn, lot number 0237747, and expiration date 2021/09/30 had been previously opened and used.The return and retention samples from the complaint batch were evaluated along with a control batch.The solution appearance for the return and retention samples was satisfactory and comparable to the control; all 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.The return sample was unsatisfactory for number of artifacts per field.This complaint has been confirmed, bd cannot determine root cause given the available information.However, the customer had stated they suspect root cause for the issue in the return bottle was due to storage conditions after opening the bottle.This complaint is the only known defect against this lot.No corrective actions are slated at this time.Bd will continue to trend complaints for artifacts in dyes/stains products.H3 other text : see h10.

• Brand Name: BD BBL¿ TB CARBOLFUCHSIN ZN
• Common Device Name: 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: 12527541
• Report Number: 1119779-2021-01567
• Device Sequence Number: 5338493
• Product Code: ICL
• UDI-Device Identifier: 00382902125112
• UDI-Public: 00382902125112
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2021

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: 212511
• Device Catalogue Number: 212511
• Device Lot Number: 0237747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2020
• 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