MAUDE Adverse Event Report: BECTON DICKINSON BD NEOFLON PRO 24GA 0.7MM OD 19MM L INDIA; INTRAVASCULAR CATHETER

Catalog Number 391390

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 03/22/2024

Event Type  malfunction  

Manufacturer Narrative

D.3.Franklin lakes has been listed as the manufacturer.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that the bd neoflon pro 24ga 0.7mm od 19mm l india label content was incorrect.The following information was provided by the initial reporter: discrepancy in outer pack and inner product in neoflon pro 24g discrepancy in lot no.

• Brand Name: BD NEOFLON PRO 24GA 0.7MM OD 19MM L INDIA
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 19121007
• MDR Text Key: 341249508
• Report Number: 2243072-2024-00554
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903913909
• UDI-Public: (01)00382903913909
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2024

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: 391390
• Device Lot Number: 3292517
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1