MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSFLOW¿ SHEATH FLUID; GENERAL PURPOSE REAGENTS

Catalog Number 342003

Device Problem Missing Information (4053)

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

Event Date 07/10/2023

Event Type  malfunction  

Event Description

It was reported that the bd facsflow¿ sheath fluid was missing the label.The following information was provided by the initial reporter: no any product label is on box.

Manufacturer Narrative

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 the bd facsflow¿ sheath fluid was missing the label.The following information was provided by the initial reporter: no any product label is on box.

Manufacturer Narrative

The following fields have been updated with corrected information: g.1 - reporting office - becton dickinson and company bd biosciences san jose ca, 95131 g.1 - reporting office contact - (b)(6) g.1 - manufacturing site contact - (b)(6) h.6.Based on the investigation results, the reported issue product with no label on box was confirmed.Investigation results that were performed on the indicated failure mode were the following: photo provided by customer shows that the product was without box.Bhr part 342003 lot 2217209819 was reviewed.The materials met all the manufacturing specifications prior to release.Due to the labeling process is automatic, the potential root cause of the complaint was operator error.Supplier has provided training to all employees involved in the packaging process.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.H3 other text : see h10.

• Brand Name: BD FACSFLOW¿ SHEATH FLUID
• Type of Device: GENERAL PURPOSE REAGENTS
• 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: 17392912
• MDR Text Key: 320054153
• Report Number: 2916837-2023-00152
• Device Sequence Number: 1
• Product Code: PPM
• UDI-Device Identifier: 00382903420032
• UDI-Public: 00382903420032
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: EXEMPT
• 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: 03/18/2024

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
• Device Operator: Other
• Device Catalogue Number: 342003
• Device Lot Number: 2217209819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2022
• 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