MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS LYSING SOLUTION 10X 150 TESTS

Catalog Number 347691

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 10/19/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd facs lysing solution 10x 150 tests contained ifu for different reagent.The following information was provided by the initial reporter: facslysing solution was received by application specialist for training purposes.The carton box with the reagent vial contained ifu for another reagent.No impact in this case as the reagent will be used by bd employee for the training and demo purposes.But if a customer receives a wrong ifu with the reagent, there might be reputation loss for bd, and the customer will have to do additional steps to get the right ifu for the reagent.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 2916837-2021-00437 was sent in error.This complaint is not mdr reportable.Per cfr regulation 809.3.This device is not considered an ivd used for clinical diagnosis and is therefore exempt from mdr reporting.

Event Description

It was reported that the bd facs lysing solution 10x 150 tests contained ifu for different reagent.The following information was provided by the initial reporter: facslysing solution was received by application specialist for training purposes.The carton box with the reagent vial contained ifu for another reagent.No impact in this case as the reagent will be used by bd employee for the training and demo purposes.But if a customer receives a wrong ifu with the reagent, there might be reputation loss for bd, and the customer will have to do additional steps to get the right ifu for the reagent.

• Brand Name: BD FACS LYSING SOLUTION 10X 150 TESTS
• Type of Device: NA
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12815320
• MDR Text Key: 284385212
• Report Number: 2916837-2021-00437
• Device Sequence Number: 1
• Product Code: GGK
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2022

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
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 347691
• Device Lot Number: 1026807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 11/15/2021
• Supplement Dates Manufacturer Received: 04/05/2022
• Supplement Dates FDA Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2021
• 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