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

Catalog Number 644611

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2023

Event Type  malfunction  

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 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¿
• Type of Device: 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 18311974
• MDR Text Key: 330293285
• Report Number: 2647876-2023-00651
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382906446114
• UDI-Public: 00382906446114
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K090967
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 644611
• Device Lot Number: 49510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1