MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD® CD16 (3G8) PERCP-CY¿5.5; CELL MARKER IVD, ANTIBODY

Catalog Number 338433

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 09/11/2023

Event Type  malfunction  

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 there was incorrect label information on the bd® cd16 (3g8) percp-cy¿5.5.The following information was provided by the initial reporter: it was reported by the customer that mislabeled cap.Mislabel of cap on the vial.338433_3135741 mislabeled cap.

Event Description

It was reported that there was incorrect label information on the bd® cd16 (3g8) percp-cy¿5.5.The following information was provided by the initial reporter: it was reported by the customer that mislabeled cap.Mislabel of cap on the vial.338433_3135741 mislabeled cap.

Manufacturer Narrative

The following fields have been updated with corrected information: (b)(4).H6.Investigation summary: based on the investigation results, the reported issue of mislabel of cap in the vial of cd16 percp-cy5.5 (asr) product was confirmed based on picture provided by customer, however, inspected retain samples did not reproduce the defect.Investigation results that were performed on the indicated failure mode were the following: customer photos showing the defect.Visual inspection of retain samples showing correct labeling.Bhr review showing product was manufacture in compliance with established processes and procedures.While the potential cause was not established due to the retain samples analysis, the customer was provided with a credit to resolve the issue.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.

• Brand Name: BD® CD16 (3G8) PERCP-CY¿5.5
• Type of Device: CELL MARKER IVD, ANTIBODY
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• 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: 17777710
• MDR Text Key: 324061634
• Report Number: 2647876-2023-00165
• Device Sequence Number: 1
• Product Code: MVU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

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: 338433
• Device Lot Number: 3135741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1