MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD BIOSCIENCES BD FACSDUET¿ SAMPLE PREP; STATION, PIPETTING DILUTING CLINICAL USE

Catalog Number	666340
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: na h.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.G.5.Pma / 510(k)#: na.
Event or Problem Description
It was reported that while using bd facsduet user bypassed error message.There was no report of user impact.The following information was provided by the initial reporter.It was reported by the customer that aspiration errors.1.Is this facspresto or facscount? if yes, no further questions required.If no, go to question #2.: no 2.Did the instrument display an error message? if yes, go to question #3.If no, no further questions required.: yes 3.What error message was displayed? (provide error code and/or description) go to question #4.: error dispensing lyse.4.Did you run a diagnostic patient assay without resolving the error message? if no, no further questions required.If yes, go to question #5 and then go to patient samples checklist.: yes.
Event or Problem Description
It was reported that while using bd facsduet user bypassed error message.There was no report of user impact.The following information was provided by the initial reporter.It was reported by the customer that aspiration errors.1.Is this facspresto or facscount? if yes, no further questions required.If no, go to question #2.: no.2.Did the instrument display an error message? if yes, go to question #3.If no, no further questions required.: yes.3.What error message was displayed? (provide error code and/or description) go to question #4.: error dispensing lyse.4.Did you run a diagnostic patient assay without resolving the error message? if no, no further questions required.If yes, go to question #5 and then go to patient samples checklist.: yes.
Additional Manufacturer Narrative
H.11 - after further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.Further information has been obtained and the customer did not bypass the error message, therefore this is not considered to be a reportable malfunction.
Event or Problem Description
It was reported that while using bd facsduet user bypassed error message.There was no report of user impact.The following information was provided by the initial reporter.It was reported by the customer that aspiration errors.1.Is this facspresto or facscount? if yes, no further questions required.If no, go to question #2.: no.2.Did the instrument display an error message? if yes, go to question #3.If no, no further questions required.: yes.3.What error message was displayed? (provide error code and/or description) go to question #4.: error dispensing lyse.4.Did you run a diagnostic patient assay without resolving the error message? if no, no further questions required.If yes, go to question #5 and then go to patient samples checklist.: yes.
Additional Manufacturer Narrative
The following fields have been updated with corrected information.H.6 imdrf annex: b21.H.6 imdrf annex: c21.H.6 imdrf annex: d16.

• Brand Name: BD FACSDUET¿ SAMPLE PREP
• Common Device Name: STATION, PIPETTING DILUTING CLINICAL USE
• 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: fahmy razak - mdr ; 2350 qume drive; san jose, CA 95131 ; 4089542435
• MDR Report Key: 20010307
• Report Number: 2916837-2024-00045
• Device Sequence Number: 19927582
• Product Code: PER
• UDI-Device Identifier: 00382906663405
• UDI-Public: (01)00382906663405(11)230704
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.11
• 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): 09/06/2024

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: 666340
• 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: 07/17/2024
• Supplement Date Received by Manufacturer: 07/17/2024; 07/17/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 08/27/2024; 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/04/2023
• 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