MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS; FLOW CTYOMETRIC REAGENTS AND ACESSORIES

Model Number	335775
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd facs¿ 7-color setup beads 25 tests that the lot number on tube does not match value printed on individual tube wrapper the tube is sealed in.The following information was provided by the initial reporter: lot number on tube does not match value printed on individual tube wrapper the tube is sealed in.
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Pma / 510(k)#: k040026, k141468.
Event or Problem Description
It was reported that while using the bd facs¿ 7-color setup beads 25 tests that the lot number on tube does not match value printed on individual tube wrapper the tube is sealed in.The following information was provided by the initial reporter: lot number on tube does not match value printed on individual tube wrapper the tube is sealed in.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 2916837-2022-00356 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.

• Brand Name: BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
• Common Device Name: FLOW CTYOMETRIC REAGENTS AND ACESSORIES
• 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: 15870415
• Report Number: 2916837-2022-00356
• Device Sequence Number: 14824264
• Product Code: GKZ
• UDI-Device Identifier: 00382903357758
• UDI-Public: 00382903357758
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K040026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2022

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: 335775
• Device Catalogue Number: 335775
• Device Lot Number: 85543
• 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: 11/18/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 12/21/2022
• 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