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

Catalog Number	335775
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	03/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G.5.Additional pma / 510(k)#: k040026, k040725, k050191, k062087.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd facs¿ 7-color setup beads 25 tests an incorrect result was reported out to a physician.There were no reports of patient harm or injury.The following information was provided by the initial reporter: they decided to run the samples after the pass with the expired beads.They should not have reported the results because of the expired 7 color set up beads, and unfortunately the results were used for inclusion/exclusion in a study.Customer confirmed that there was no harm, negative impact, or injury to the patient as far as they know.
Event or Problem Description
It was reported that while using bd facs¿ 7-color setup beads 25 tests an incorrect result was reported out to a physician.There were no reports of patient harm or injury.The following information was provided by the initial reporter: they decided to run the samples after the pass with the expired beads.They should not have reported the results because of the expired 7 color set up beads, and unfortunately the results were used for inclusion/exclusion in a study.Customer confirmed that there was no harm, negative impact, or injury to the patient as far as they know.
Additional Manufacturer Narrative
H.6.Investigation summary: based on the investigation results, the reported issue of qc failure which caused erroneous results was confirmed.Investigation results that were performed on the indicated failure mode were the following: complaint history review: the potential cause was due to the use of expired beads.The field service engineer (fse) also confirmed that although the lot number was correct the target voltages were all set to default and the spectral overlaps were also set to 100.The fse inputted the correct values and the issue was resolved.

• 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; 155 north mccarthy boulevard; milpitas CA 95035
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 155 north mccarthy boulevard; milpitas CA 95035
• Manufacturer Contact: fahmy razak - mdr ; vicks drive; lot no. 1; cayey, PR ; 7877384245
• MDR Report Key: 21719506
• Report Number: 3027394506-2025-00010
• Device Sequence Number: 9492065
• Product Code: OYE
• UDI-Device Identifier: 00382903389629
• UDI-Public: (01)00382903389629(11)230601(17)250630(10)85587
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141468
• 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): 04/08/2025

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: 06/30/2025
• Device Catalogue Number: 335775
• Device Lot Number: 85587
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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