MAUDE Adverse Event Report: BD SUZHOU (MDS) BD NEXIVA 24 GA X 3/4 IN SINGLE PORT; INTRAVASCULAR CATHETER

Catalog Number	383511
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva 24 ga x 3/4 in single port label content incorrect this is a complaint about the ¿size identification color¿ printed on the back of the individual packaging is different.When sorting at the hospital spd, customer noticed that the ¿size identification color¿ for 24g printed on the back of the individual packaging should be yellow, but 12 of the 20 items (1 sp) are printed in green (same color as 18g).The other 8 items are yellow, and the lot numbers within this 1 sp are all the same (both green and yellow).
Additional Manufacturer Narrative
Our quality engineer inspected the photos submitted for evaluation.The reported issue of label content incorrect was confirmed upon inspection of the photos.The cause of this defect is human error during the changeover operation, as the information is correct but using the wrong top web paper.This could be due to concurrently purging the old top web while loading the good parts.This resulted in the old top web being used with the new information being mixed in with the good parts.To prevent this defect, installation of a color sensor will be completed to identify the top web paper color during major changeovers.This will help ensure the machine rejects incorrectly colored top webs.Awareness training will be completed with production associates about this customer complaint, including a retraining on the line clearance procedure.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.We appreciate you taking the time to bring this observation to our attention.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.We regret any inconveniences this incident may have caused you and your facility.

• Brand Name: BD NEXIVA 24 GA X 3/4 IN SINGLE PORT
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21868589
• Report Number: 2243072-2025-00549
• Device Sequence Number: 18117303
• Product Code: FOZ
• UDI-Device Identifier: 00382903835119
• UDI-Public: (01)00382903835119(11)241012(17)270930(10)4286577
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2025

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: Health Professional
• Device Catalogue Number: 383511
• Device Lot Number: 4286577
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown