MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON PRO SAFETY 20GA 1.1MM; INTRAVASCULAR CATHETER

Catalog Number 393224

Device Problem Defective Component (2292)

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

Event Date 03/22/2024

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 the bd venflon pro safety 20ga 1.1mm safety shield activation failed.The following information was provided by the initial reporter translated from italian to english."incident description : after placing the needle into the venoid, at the moment that i displaced the spindle, it flipped.The mandrel, the mandrel rubbed into the walls of the cannula bringing it behind and causing the whole device to come out." involved: patient age: 50 the device was used: yes use: first use consequence : other consequence : need to get another venous access to the patient (multiple venipuncture).Number of pieces involved : (b)(4) device availability : no.

Event Description

Incident description : after placing the needle into the venoid, at the moment that i displaced the spindle, it flipped.The mandrel, the mandrel rubbed into the walls of the cannula bringing it behind and causing the whole device to come out.Involved: patient.Age: 50.The device was used: yes.Use: first use.Consequence : other.Other consequence : need to get another venous access to the patient (multiple venipuncture).Number of pieces involved : 1.Device availability : no.

Manufacturer Narrative

As no sample and no photo were returned, further investigation cannot be performed.Visual inspection and functional test were performed per control plan.Dhr was reviewed and no abnormality was reported.No similar quality notification was raised for the reported defect in the past 12 months.Therefore, the root cause cannot be determined.Complaint trend would be monitored and complaint will be reopened when sample is returned.

• Brand Name: BD VENFLON PRO SAFETY 20GA 1.1MM
• 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: 19206986
• MDR Text Key: 341354676
• Report Number: 2243072-2024-00577
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903932245
• UDI-Public: (01)00382903932245
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

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: 393224
• Device Lot Number: 3274476
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR