MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD LEUCOCOUNT¿; COUNTER, DIFFERENTIAL CELL

Catalog Number	341003
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was foreign matter/ contamination in the reagent during use with the bd leucocount¿.The following information was provided by the initial reporter: after each thermo cycle use of the combo control, debris is increasing, which is starting to impact the bead count.Customer would like to investigate the issue.Box was opened last week and has gone through 3 thermal cycles.
Additional Manufacturer Narrative
G.5.Pma / 510(k)#: bk000035.G.5.Pma / 510(k)#: bk000036.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information: annex f code was corrected to f26 reporting office: becton dickinson and company bd biosciences - san jose reporting office contact: fahmy razak - mdr manufacturing location: becton dickinson and company bd biosciences- san jose manufacturing site contact: fahmy razak - mdr h.6: bd acknowledges the customer¿s experience regarding the indicated failure mode of increasing debris which started to impact the bead count with the reported customer event on bd leucocount combo rbc/plt control kit (341003-lc0723).Based on the investigation results conducted and provided by the supplier on retain sample: the data is in range.Product history review as reported by the supplier, the product was within specification limits when released.The reported issue was not confirmed.No serious injury, death, erroneous results, or treatment change were reported that affect a patient safety.Bd is continually monitoring complaints received for this product and reported failures in order to identify emerging trends.H3 other text : see h.10.
Event or Problem Description
It was reported that there was foreign matter/ contamination in the reagent during use with the bd leucocount¿.The following information was provided by the initial reporter: after each thermo cycle use of the combo control, debris is increasing, which is starting to impact the bead count.Customer would like to investigate the issue.Box was opened last week and has gone through 3 thermal cycles.

• Brand Name: BD LEUCOCOUNT¿
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• 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; suite no. 210; san jose CA 95131
• Manufacturer Contact: fahmy razak - mdr ; 2350 qume drive; san jose, CA 95131 ; 4089542435
• MDR Report Key: 17477582
• Report Number: 2916837-2023-00159
• Device Sequence Number: 11489368
• Product Code: GKZ
• UDI-Device Identifier: 00382903410033
• UDI-Public: 00382903410033
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2024

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 Expiration Date: 09/05/2023
• Device Catalogue Number: 341003
• Device Lot Number: LC0723
• 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: 07/10/2023
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2023
• 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