MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD® FC BEADS 7-COLOR KIT

Model Number	662961
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd® fc beads 7-color kit that there was incorrect label information.The following information was provided by the initial reporter: i am performing reference setting updates and noted the following with this lot#2339327 of 7 colour fc beads when i used the barcode sticker to add the new fc bead lot information the tube lot#' s in the box did not match the lot numbers from the scanned barcode.When i went and downloaded the bead-lot file from online, it was correct.Just wanted to give you a heads up.
Additional Manufacturer Narrative
Pma/510(k)# k170974, k201814.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 2916837-2023-00037 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.
Event or Problem Description
It was reported that while using the bd® fc beads 7-color kit that there was incorrect label information.The following information was provided by the initial reporter: i am performing reference setting updates and noted the following with this lot#2339327 of 7 colour fc beads when i used the barcode sticker to add the new fc bead lot information the tube lot #s in the box did not match the lot numbers from the scanned barcode.When i went and downloaded the bead-lot file from online, it was correct.Just wanted to give you a heads up.

• Brand Name: BD® FC BEADS 7-COLOR KIT
• Common Device Name: NA
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16381065
• Report Number: 2916837-2023-00037
• Device Sequence Number: 6142765
• Product Code: OYE
• UDI-Device Identifier: 00382906629616
• UDI-Public: 00382906629616
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K170974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2023

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: 662961
• Device Catalogue Number: 662961
• Device Lot Number: 2339327
• 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: 02/08/2023
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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