MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BOTTLE TB AURAMINE M 250ML; SYSTEM, BLOOD CULTURING

Model Number	212514
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	08/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bottle tb auramine m 250ml experienced biological contamination.The following information was provided by the initial reporter: customer reported sediments/precipitates in their bottle of tb auramine m stain from lot 0288107, exp: 2021-10-31 (cat# 212514).They are using the tb fluorescent stain kit m for the morse coloration.She didn¿t provide the stain kit lot number.
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-09-20.H6: investigation summary the following summary is in response against material 212514, and lot 0288107 for precipitate defects.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 tb auramine m.The batch history record review indicated no discrepancies.All release testing was satisfactory.Satisfactory appearance per the bd coa is ¿yellow suspension¿.By definition a suspension is ¿a mixture in which particles are dispersed throughout the bulk of the fluid¿.It is also defined as ¿a mixture in which all particles of a substance are dispersed throughout a gas or liquid.If a suspension is left undisturbed, the particles are likely to settle to the bottom.The particles in a suspension are larger than those in either a colloid or a solution¿.Complaint trends were reviewed for a period covering 12 months.During that time there have been no confirmed complaints for the defect in question for this product.The return received on 09/20/21.The return bottle was previously opened and almost empty.The return and retention samples from the complaint batch were evaluated along with a control batch of tb auramine m.There was a large amount of particulate visible in the return and retention samples as well as the control.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 return, retention and control batches.The return and retention samples were comparable to the control.The presence of the particles is not considered a product defect for tb auramine, as they are expected to be present within the suspension, and allowable per claims on this product.Consequently, this complaint cannot be confirmed.H3 other text : see h10.
Event or Problem Description
It was reported that the bottle tb auramine m 250ml experienced biological contamination.The following information was provided by the initial reporter: customer reported sediments/precipitates in their bottle of tb auramine m stain from lot 0288107, exp: 2021-10-31 (cat# 212514).They are using the tb fluorescent stain kit m for the morse coloration.She didn¿t provide the stain kit lot number.

• Brand Name: BOTTLE TB AURAMINE M 250ML
• Common Device Name: SYSTEM, BLOOD CULTURING
• 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: 12558067
• Report Number: 1119779-2021-01599
• Device Sequence Number: 11838876
• Product Code: KJK
• UDI-Device Identifier: 00382902125143
• UDI-Public: 00382902125143
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,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: 10/31/2021
• Device Model Number: 212514
• Device Catalogue Number: 212514
• Device Lot Number: 0288107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2021
• Supplement Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2020
• 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