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

Catalog Number 393226

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2014

Event Type  Injury  

Event Description

It was reported that a bd venflon pro safety iv catheter broke and that the catheter remained inside the pt.The pt required surgery to remove the broken piece of catheter.

Manufacturer Narrative

It is unk if a sample will be received.If a sample is returned it will be evaluated and upon completion of the investigation, a supplemental report will be filed.

• Brand Name: BD VENFLON PRO SAFETY IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton dr.; franklin lakes NJ 07417
• Manufacturer Contact: aaron larson ; 1 becton dr.; franklin lakes, NJ 07417 ; 8015652406
• MDR Report Key: 4273039
• MDR Text Key: 5008545
• Report Number: 2243072-2014-00287
• 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,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/17/2014

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 Expiration Date: 03/31/2017
• Device Catalogue Number: 393226
• Device Lot Number: 4086312P47
• Initial Date Manufacturer Received: 11/07/2014
• Initial Date FDA Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2014
• 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
• Patient Age: 93 YR