MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD MULTITEST¿; COUNTER, DIFFERENTIAL CELL

Catalog Number	644611
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	11/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Initial reporter facility name: (b)(6).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 there was contamination in the reagent during use with the bd multitest¿.The following information was provided by the initial reporter: recent change to new lot tbnk 49510, exp 30.09.2024 reagent has found more samples with much higher debris/noise level on cd45 low vs ssc and fcs.Almost all samples in the run have the debits express positive staining on all the markers of tbnk panel.We¿ve already done many steps of cleaning and troubleshooting on the bd facscanto ii instrument.Debri persists.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: g.1 - reporting office - (b)(6).G.1 - reporting office contact - (b)(6).G.1 - manufacturing site contact - (b)(4).H.6 investigation summary: based on the investigation results, the reported issue (non-specific staining creating unusual staining patterns for cd4+cd+8 populations) was confirmed.Investigation results that were performed on the indicated failure mode were the following: - data provided by customer was reviewed.- retain testing results showed the presence of a non-specific staining.- potential cause is determined to be manufacturing related.- additional controls have been put in place in the manufacturing stage specific to the supplied component.- corrective action was initiated to address the root cause and preventive actions.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 there was contamination in the reagent during use with the bd multitest¿.The following information was provided by the initial reporter: recent change to new lot tbnk 49510, exp 30.09.2024 reagent has found more samples with much higher debris/noise level on cd45 low vs ssc and fcs.Almost all samples in the run have the debits express positive staining on all the markers of tbnk panel.We¿ve already done many steps of cleaning and troubleshooting on the bd facscanto ii instrument.Debri persists.

• Brand Name: BD MULTITEST¿
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: fahmy razak - mdr ; 2350 qume drive; san jose, CA 95131 ; 4089542435
• MDR Report Key: 18311974
• Report Number: 2647876-2023-00651
• Device Sequence Number: 6626382
• Product Code: GKZ
• UDI-Device Identifier: 00382906446114
• UDI-Public: 00382906446114
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: 09/30/2024
• Device Catalogue Number: 644611
• Device Lot Number: 49510
• 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: 11/17/2023
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES# 94830
• Patient Sequence Number: 1
• Patient Sex: Unknown