MAUDE Adverse Event Report: BECTON DICKINSON BD INTIMA-II IV CATHETER 24G X 0.75"; INTRAVASCULAR CATHETER

Catalog Number 383408

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Embolism (1829); Test Result (2695)

Event Date 01/08/2015

Event Type  Injury  

Event Description

It was reported that upon removal of a bd intima-ii iv catheter, the catheter had broken.The patient received an x-ray and an ultrasound which located the broken catheter in the patient's vein.The patient had surgery and the broken catheter was removed.

Manufacturer Narrative

A sample is not available for evaluation.However, photos of the used device have been received and will be evaluated.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

• Brand Name: BD INTIMA-II IV CATHETER 24G X 0.75"
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton dr.; franklin lakes NJ 07417
• Manufacturer Contact: aaron lawson ; 1 becton dr.; franklin lakes, NJ 07417 ; 8015652406
• MDR Report Key: 4629624
• MDR Text Key: 17943946
• Report Number: 2243072-2015-00045
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/20/2015

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: 08/31/2017
• Device Catalogue Number: 383408
• Device Lot Number: 4260131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2015
• Initial Date FDA Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2014
• 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