MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD BIOSCIENCES BD FACSLYRIC¿; FLOW CYTOMETRIC REAGENTS AND ACCESS

Catalog Number	663518
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd facslyric¿ flow cytometer contamination of a patient sample occurred.There was no report of user impact.The following information was provided by the initial reporter."it was reported by customer that sit dripping." ¿mdr safety checklist : contamination : 1.Were samples contaminated? (if no, no further questions required.If yes or unknown, go to patient samples checklist): yes.Mdr safety checklist : patient samples 1.Are there erroneous results on patient samples from diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required.): yes.2.Was there any delay of treatment due to the issue? (go to question #3): no.3.If patient samples were redrawn, was there any change or delay of treatment? (go to question #4): not applicable.4.Was there any physical harm/injury to the patient due to the issue? (if yes or unknown, go to question #5.If no, no further questions required): no.
Additional Manufacturer Narrative
E.1 initial reporter address: (b)(6).G5.Pma / 510(k)#: bk230835, k170974, k201814.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6 based on the investigation results, the reported issue for the sit dripping was confirmed.Investigation results that were performed on the indicated failure mode were the following: the potential cause for the sit dripping was an adjustment for the v8 valve tubing the customer reported a complaint regarding the sit dripping.The field service representative (fsr) performed a field visit and performed a repair.They moved the tubing on v8 valve.After the adjustment the instrument was tested and was performing as intended.Although the instrument was used for diagnostic testing, the issue was identified and resolved before erroneous patient sample results were used for any diagnosis or treatment.Neither the customer nor any patients were harmed due to this issue.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that while using bd facslyric¿ flow cytometer contamination of a patient sample occurred.There was no report of user impact.The following information was provided by the initial reporter."it was reported by customer that sit dripping." ¿mdr safety checklist : contamination : 1.Were samples contaminated? (if no, no further questions required.If yes or unknown, go to patient samples checklist): yes.Mdr safety checklist : patient samples 1.Are there erroneous results on patient samples from diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required.): yes.2.Was there any delay of treatment due to the issue? (go to question #3): no.3.If patient samples were redrawn, was there any change or delay of treatment? (go to question #4): not applicable.4.Was there any physical harm/injury to the patient due to the issue? (if yes or unknown, go to question #5.If no, no further questions required): no.

• Brand Name: BD FACSLYRIC¿
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESS
• 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: 19080227
• Report Number: 2916837-2024-00026
• Device Sequence Number: 12227298
• Product Code: OYE
• UDI-Device Identifier: 00382906635181
• UDI-Public: (01)00382906635181
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10
• 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
• Report Date (Section B): 06/27/2024

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: 663518
• 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: 03/15/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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