MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ SAMPLE PREP ASSISTANT III; AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTO

Catalog Number	647205
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during use of bd facs¿ sample prep assistant iii, foreign matter/contamination in instrument that impacted patient results was observed.Contaminant is in a position where it impacted a readout to be used clinically.There was no patient impact.The following information was provided by the initial reporter: it was reported by the customer that samples not being processed correct.Customer replaced syringe but issue persists.Patient samples checklist: 1.Did this cause erroneous results on patient samples for diagnostic testing? if yes, go to question #2.If no, no further questions required.Yes.2.Was an erroneous laboratory result from the bdb product reported to a clinician? if yes, go to question #3.If no, no further questions required.No.Contamination: 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.Patient samples contaminated.2.Please describe any additional details: go to patient samples checklist.Samples were not properly processed and there was a red tinge (blood) to the completed samples.Customer identified this is not correct so they stopped using system.Customer then manually processed samples by hand.
Event or Problem Description
It was reported that during use of bd facs¿ sample prep assistant iii, foreign matter/contamination in instrument that impacted patient results was observed.Contaminant is in a position where it impacted a readout to be used clinically.There was no patient impact.The following information was provided by the initial reporter: it was reported by the customer that samples not being processed correct.Customer replaced syringe but issue persists.Patient samples checklist: 1.Did this cause erroneous results on patient samples for diagnostic testing? if yes, go to question #2.If no, no further questions required.Yes.2.Was an erroneous laboratory result from the bdb product reported to a clinician? if yes, go to question #3.If no, no further questions required.No.Contamination: 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.Patient samples contaminated 2.Please describe any additional details: go to patient samples checklist.Samples were not properly processed and there was a red tinge (blood) to the completed samples.Customer identified this is not correct so they stopped using system.Customer then manually processed samples by hand.
Additional Manufacturer Narrative
The following field was updated with corrected information: h.6 imdrf annex g: g04135 valve(s).H.6 investigation summary: based on the investigation results, the reported issue of the customer experiencing samples not being processed after testing was confirmed.Investigation results that were performed on the indicated failure mode were the following: the complaint trend and service notes were reviewed.The potential cause for the customer experiencing samples not being processed was linked to the 4-way valve.The issue was resolved after the part was replaced.The replaced part was not returnable; therefore, it was discarded.No further problems were noted, and the instrument was confirmed to be functioning as expected.Although the instrument was used for diagnostic testing, the issue was resolved before the patient sample results were used for any diagnosis or treatment.
Additional Manufacturer Narrative
The following field was updated with corrected information: h.6 investigation summary: based on the investigation results, the reported issue of the customer experiencing contamination after testing was confirmed.Investigation results that were performed on the indicated failure mode were the following: the complaint trend and service notes were reviewed.The potential cause for the customer experiencing contamination was linked to the 4-way valve.The issue was resolved after the part was replaced.The replaced part was not returnable; therefore, it was discarded.No further problems were noted, and the instrument was confirmed to be functioning as expected.Although the instrument was used for diagnostic testing, the issue was resolved before the patient sample results were used for any diagnosis or treatment.
Event or Problem Description
It was reported that during use of bd facs¿ sample prep assistant iii, foreign matter/contamination in instrument that impacted patient results was observed.Contaminant is in a position where it impacted a readout to be used clinically.There was no patient impact.The following information was provided by the initial reporter: it was reported by the customer that samples not being processed correct.Customer replaced syringe but issue persists.Patient samples checklist: 1.Did this cause erroneous results on patient samples for diagnostic testing? if yes, go to question #2.If no, no further questions required.Yes 2.Was an erroneous laboratory result from the bdb product reported to a clinician? if yes, go to question #3.If no, no further questions required.No contamination: 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.Patient samples contaminated 2.Please describe any additional details: go to patient samples checklist.Samples were not properly processed and there was a red tinge (blood) to the completed samples.Customer identified this is not correct so they stopped using system.Customer then manually processed samples by hand.

• Brand Name: BD FACS¿ SAMPLE PREP ASSISTANT III
• Common Device Name: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTO
• 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 ; 155 north mccarthy boulevard; milpitas, CA 95035 ; 8772328995
• MDR Report Key: 24277294
• Report Number: 3027394506-2026-00002
• Device Sequence Number: 8253820
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: (01)00382906472052(11)120322
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K131301
• 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,Followup
• Report Date (Section B): 04/16/2026

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 Catalogue Number: 647205
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 04/14/2026; 04/16/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 04/16/2026; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2012
• 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