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

Catalog Number	335775
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G.5.Pma / 510(k)#: k040725.G.5.Pma / 510(k)#: k050191.G.5.Pma / 510(k)#: k062087.G.5.Pma / 510(k)#: k141468.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd facs¿ 7-color setup beads 25 tests contamination was observed.There was no report of user impact.The following information was provided by the initial reporter: "failing lot"."1.Were patient samples contaminated or was there carryover (cross-contamination/mixing) between patient samples? if no, no further questions required.Patient samples contaminated, carryover between patient samples, unknown - go to question #2.Yes.2.Please describe any additional details: go to patient samples checklist.Patient samples checklist: 1.Did this cause erroneous results on patient samples for diagnostic testing? if yes, go to question #2.Yes.If no, no further questions required.2.Was an erroneous laboratory result from the bdb product reported to a clinician? if yes, go to question #3.No.
Event or Problem Description
It was reported that while using bd facs¿ 7-color setup beads 25 tests contamination was observed.There was no report of user impact.The following information was provided by the initial reporter: "failing lot" "1.Were patient samples contaminated or was there carryover (cross-contamination/mixing) between patient samples? if no, no further questions required.Patient samples contaminated, carryover between patient samples, unknown - go to question #2.Yes 2.Please describe any additional details: go to patient samples checklist.Patient samples checklist: 1.Did this cause erroneous results on patient samples for diagnostic testing? if yes, go to question #2.Yes, if no, no further questions required.2.Was an erroneous laboratory result from the bdb product reported to a clinician? if yes, go to question #3.No.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.New information obtained confirms that no contamination/carryover occurred, therefore, this is not considered to be a reportable malfunction.

• Brand Name: BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESSORIES
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 155 north mccarthy boulevard; milpitas CA 95035
• Manufacturer (Section G): BD CARIBE, LTD; vicks drive; lot no. 1; cayey PR
• Manufacturer Contact: fahmy razak - mdr ; 155 north mccarthy boulevard; milpitas, CA 95035 ; 8772328995
• MDR Report Key: 21988548
• Report Number: 3008352382-2025-00001
• Device Sequence Number: 20952375
• Product Code: OYE
• UDI-Device Identifier: 00382903357758
• UDI-Public: (01)00382903357758(11)250304(17)250930(10)85638
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 05/21/2025

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: 09/30/2025
• Device Catalogue Number: 335775
• Device Lot Number: 85638
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2025
• 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