MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ SAMPLE PREP ASSISTANT III; SEE H.10

Model Number	647205
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common device name: automated pipetting, diluting and specimen processing workstations for flow cytometric analysis.Initial reporter addr 1: (b)(6).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 the bd facs¿ sample prep assistant iii that there was a waste leak.The following information was provided by the initial reporter: leakage at wash station.
Event or Problem Description
It was reported that while using the bd facs¿ sample prep assistant iii that there was a waste leak.The following information was provided by the initial reporter: leakage at wash station.
Additional Manufacturer Narrative
Bdb has monitored its mdr reporting, and after review, has determined through valid data that: (1) the relevant malfunctions have not caused or contributed to further deaths or serious injuries for two years, and (2) the likelihood of another death or serious injury as a result of the relevant malfunctions is remote.Accordingly, bdb has amended its mdr reporting guidelines to discontinue further presumptive reporting of malfunctions associated with liquid leakage and splash complaints.Mfr.# 2916837-2023-00048 was filed under previous guidance and is now corrected to be a non-reportable event.Ii.The aforementioned amendment to the bdb mdr reporting guidelines was based on the following rationale: to evaluate the impact of this proposed change, an assessment of the complaint and adverse event reporting history was performed for malfunctions associated with serious injuries or deaths related to liquid leakage and splash events.The assessment confirms there have been no reports of serious injury or death related to liquid leakage or splash events for the last two years (sep.2020 thru nov.2022).Iii.We also note that the likelihood of another death or serious injury as a result of the relevant malfunctions is remote.Specifically, a liquid leakage or splash of a chemical or potentially biohazardous fluid would be readily apparent to the user and is unlikely to come in contact with eyes, mouth, other mucous membrane, and non-intact skin, or cause parenteral contact with blood or other potentially infectious materials.Users are also instructed to follow universal precautions including wearing ppe per the products user documentation, and the requirements in the osha bloodborne pathogen guideline.As such, the risk of serious injury or death occurring related to malfunctions causing liquid leakage or splash events would be improbable.H3 other text : see h.10.

• Brand Name: BD FACS¿ SAMPLE PREP ASSISTANT III
• Common Device Name: SEE H.10
• 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 ; 8448235433
• MDR Report Key: 16455700
• Report Number: 2916837-2023-00048
• Device Sequence Number: 6452342
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: 00382906472052
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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: 647205
• 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: 02/15/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2012
• 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