MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON PRO SAFETY; IV CATHETER

Catalog Number 393224

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/12/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the reported stated that on (b)(6) 2014, the patient had surgery a venflon pro safety was inserted in the right hand.On (b)(6) 2014, the catheter was removed.On (b)(6) 2014, the patient returned to the hospital because he had an induration at the insertion site.The x-ray didn't show any foreign matter or piece of cannula.The echography showed a tubular body (diameter 2mm length 25mm) in the vein of the right hand.On (b)(6) 2014, the patient had the surgical intervention to remove the broken cannula but they couldn't find any foreign matter.No add'l info is available or anticipated.

Manufacturer Narrative

No samples or photos were returned therefore the complaint could not be confirmed and the root cause is undetermined.The incident has been added to our database and will be tracked for emerging trends.If samples are rec'd in the future the complaint will be reopened for further investigation.Unable to run complaint history check or device history review as lot number is unknown.Quality will continue to monitor on monthly trend reports.

• Brand Name: BD VENFLON PRO SAFETY
• Type of Device: IV CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton dr.; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL; 9450 south state street; sandy UT 84070
• Manufacturer Contact: elizabeth closner, rn, bsn ; 1 becton dr.; franklin lakes, NJ 07417 ; 2105265165
• MDR Report Key: 3682855
• MDR Text Key: 19769660
• Report Number: 2243072-2014-00036
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 393224
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/21/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2014
• Initial Date FDA Received: 03/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention