MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ TB STAIN KIT ZN; STAINS, MICROBIOLOGIC

Model Number	212520
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	11/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that 1 bd bbl¿ tb stain kit zn was contaminated.There was no report of patient impact.The following information was provided by the initial reporter: customer observed particulates looking like solid circles after staining mycobacteria, and the occurrence was observed with both old, expired lot of reagents and when using a new one.
Additional Manufacturer Narrative
H.6.Investigation: the following summary is in reference to the complaint, against material 212520, lot 1207336 for solution appearance-particulates.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 stain kit zn, lot 1207336.The batch history record reviews indicated no discrepancies.Release testing consists of component appearance and performance testing using appropriate tb stain technique.All release testing was satisfactory.Complaint trends were reviewed for a period covering 12 months.During that time there have been no complaints against this dyes and stains kit for any defects.No returns or photos were received.A retention sample from the complaint batch was evaluated along with a control batch.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.Bd is unable to replicate the particulate defect observed by the customer in the complaint lot.Consequently, this complaint cannot be confirmed.Bd will continue to trend dyes and stains complaints for solution appearance defects.If you have further questions, please contact bd technical services.
Event or Problem Description
It was reported that 1 bd bbl¿ tb stain kit zn was contaminated.There was no report of patient impact.The following information was provided by the initial reporter: customer observed particulates looking like solid circles after staining mycobacteria, and the occurrence was observed with both old, expired lot of reagents and when using a new one.

• Brand Name: BD BBL¿ TB STAIN KIT ZN
• Common Device Name: STAINS, MICROBIOLOGIC
• 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: 12921040
• Report Number: 1119779-2021-01909
• Device Sequence Number: 5207452
• Product Code: JTS
• UDI-Device Identifier: 00382902125204
• UDI-Public: 00382902125204
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2021

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 Model Number: 212520
• Device Catalogue Number: 212520
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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