MAUDE Adverse Event Report: BECTON DICKINSON BD NEOFLON PRO 26GA 0.6MM OD 19MM; INTRAVASCULAR CATHETER

Catalog Number 391379

Device Problem Defective Component (2292)

Patient Problems Extravasation (1842); Skin Disorders (4543)

Event Date 11/30/2023

Event Type  Injury  

Manufacturer Narrative

Our quality engineer inspected the 2 representative samples submitted for evaluation.The reported issue of cap tight was not confirmed upon inspection of the samples.Analysis of the sample showed no damages or defect.The white plug could be removed from the cannula hub luer lock with no functionality issue.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.Due to the defect not being able to be replicated, a root cause could not be determined.

Event Description

It was reported that bd neoflon pro 26ga 0.6mm od 19mm cap tight the following information was provided by the initial reporter: cannula white cap is very difficult to remove from the cannula haub and gets stuck.So they can open the cap so diffucult.So the cannula can be damaged and dislodged easily.They had one extravasation.At the same time, they state that when they remove the cannula, they see a serious disruption in the integrity of the skin where the cannula exits, and that they apply treatment to heal this area.Cannula white cap is very difficult to remove from cannula hub and gets stuck, also nfc and infusion sets are same.

• Brand Name: BD NEOFLON PRO 26GA 0.6MM OD 19MM
• 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: 18406004
• MDR Text Key: 331471799
• Report Number: 2243072-2023-02245
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 12/27/2023

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: 391379
• Device Lot Number: 2307936P64
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1