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	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that carryover was observed during use with the bd facslyric¿.The following information was provided by the initial reporter: after just recently discussing with account here are the current conclusions: 1) there seemed to be one patient affected, account called yesterday afternoon for carryover issues at end of day.
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.
Event or Problem Description
It was reported that carryover was observed during use with the bd facslyric¿.The following information was provided by the initial reporter: after just recently discussing with account here are the current conclusions: 1) there seemed to be one patient affected, account called yesterday afternoon for carryover issues at end of day.
Additional Manufacturer Narrative
H6: based on the investigation results, the reported issue of carryover was confirmed.The potential cause was determined to be a loose sit probe fitting and a deteriorated waste check valve.The field service engineer (fse) investigated the issue and replaced various fluidics components including the sit probe and the check valve, which resolved the issue and returned the instrument to operational status.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 the complaint was confirmed through other elements of the investigation.Review of the device history record (dhr) confirmed that the instrument met all the manufacturing specifications prior to release.
Event or Problem Description
It was reported that carryover was observed during use with the bd facslyric¿.The following information was provided by the initial reporter: after just recently discussing with account here are the current conclusions: 1) there seemed to be one patient affected, account called yesterday afternoon for carryover issues at end of day.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: d.4.Unique identifier (udi) #: (b)(6).

• 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: 19382696
• Report Number: 2916837-2024-00033
• Device Sequence Number: 12387092
• Product Code: OYE
• UDI-Device Identifier: 00382906635181
• UDI-Public: (01)00382906635181(11)191230(21)Z663518000051
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K201814
• 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): 09/23/2024

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: 04/25/2024
• Supplement Date Received by Manufacturer: 04/25/2024; 09/23/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 08/27/2024; 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2019
• 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