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

Catalog Number 391380

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/15/2023

Event Type  malfunction  

Manufacturer Narrative

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 bd neoflon pro 24ga 0.7mm od 19mm l needle was discolored the following information was provided by the initial reporter: the problem occurred in the rheumatology department.The user was a pediatric rheumatology fellow in training.The fellow noticed that there was an extra bevel that was located on the upper third of the iv cannula causing the vein to collapse whenever it was inserted.It caused discomfort to their (s) and also added expense.Upon visiting the rheumatology department this afternoon, we found out that the used to use 'bd neoflon' and the current cannula they are using if 'bd neoflon pro'.We were able to explain clearly the difference with both cathethers, specially the instaflash technology which was the reason for the 'extra bevel' that they were referring to.However they also had a concern regarding the needle itself.The nurse that we talked to said that it had visible black discoloration in the needle.She also showed me that the needle was hard to pull in the removable wing part.

Manufacturer Narrative

13 samples (24g x7, 26g x6) returned in opened package pass the visual inspection.No abnormality is observed.Dhr was reviewed and no abnormality was reported.No similar quality notification was raised for the reported defect in the past 12 months.The needle of neoflon pro has a notch design.It is a feature in neoflon pro design for the instaflash needle technology.The notch will appear to be darker in appearance inside the catheter (refer to figure 6 in attachment a), it is not a defect.Based on verbatim, customer is transitioned from neoflon to neoflon pro.Marketing team had been informed to engage with customer and provide necessary user training.

Event Description

The problem occurred in the rheumatology department.The user was a pediatric rheumatology fellow in training.The fellow noticed that there was an extra bevel that was located on the upper third of the iv cannula causing the vein to collapse whenever it was inserted.It caused discomfort to their (s) and also added expense.Upon visiting the rheumatology department this afternoon, we found out that the used to use 'bd neoflon' and the current cannula they are using if 'bd neoflon pro'.We were able to explain clearly the difference with both cathethers, specially the instaflash technology which was the reason for the 'extra bevel' that they were referring to.However they also had a concern regarding the needle itself.The nurse that we talked to said that it had visible black discoloration in the needle.She also showed me that the needle was hard to pull in the removable wing part.

• Brand Name: BD NEOFLON PRO 24GA 0.7MM OD 19MM L
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18479516
• MDR Text Key: 332470118
• Report Number: 2243072-2023-02293
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: RP
• 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,Followup
• Report Date: 02/06/2024

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: Health Professional
• Device Catalogue Number: 391380
• Device Lot Number: 2133274
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1