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

Catalog Number	647205
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while washing the filter of the bd facs¿ sample prep assistant iii, liquid splashed into the user¿s eyes.The user was not wearing the appropriate ppe as specified in the ifu, and there was no product failure associated with the instrument.The following information was provided by the initial reporter: the user reported that the previous week, during user maintenance, when the filter of this equipment was opened, she was splashed with liquid from the equipment's waste products into her eyes.The user reported this and followed the institution's procedures for this type of situation, but it was only after the engineer's visit that the incident was reported to bd.Additional information provided by the technical services team: the incident occurred when the user was washing the instrument¿s filter, after it had been removed from the equipment.It is reported that the user removed the filter without any issues, and while washing it under running water, liquid splashed into their eyes.The user was not wearing safety glasses.There are no complaints of problems related to the instrument or bd disposables.There were no immediate consequences for the user at the time of the event; however, user is currently on prophylactic medication due to what happened.
Additional Manufacturer Narrative
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 washing the filter of the bd facs¿ sample prep assistant iii, liquid splashed into the user¿s eyes.The user was not wearing the appropriate ppe as specified in the ifu, and there was no product failure associated with the instrument.The following information was provided by the initial reporter: the user reported that the previous week, during user maintenance, when the filter of this equipment was opened, she was splashed with liquid from the equipment's waste products into her eyes.The user reported this and followed the institution's procedures for this type of situation, but it was only after the engineer's visit that the incident was reported to bd.Additional information provided by the technical services team: the incident occurred when the user was washing the instrument¿s filter, after it had been removed from the equipment.It is reported that the user removed the filter without any issues, and while washing it under running water, liquid splashed into their eyes.The user was not wearing safety glasses.There are no complaints of problems related to the instrument or bd disposables.There were no immediate consequences for the user at the time of the event; however, user is currently on prophylactic medication due to what happened.
Additional Manufacturer Narrative
H.6 investigation summary: based on the investigation results, the reported issue of a splash of liquid into the user's eyes was confirmed.The potential cause was determined to be a lack of user protective personal equipment (ppe).There is no issue with the instrument or the user maintenance procedures.This issue did not impact patient diagnosis or treatment, and no user or patient was harmed or injured.The complaint sample was not requested to be returned because no parts were replaced.Device history record review was not required as the complaint was confirmed through other elements of the investigation.

• Brand Name: BD FACS¿ SAMPLE PREP ASSISTANT III
• Common Device Name: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING FOR FLOW CYTOMETRY
• 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: 23794926
• Report Number: 3027394506-2025-00048
• Device Sequence Number: 5522224
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: (01)00382906472052(11)120322
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown