MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON PRO SAFETY IV CARHETER 20 G; INTRACASCULAR CATHETER

Catalog Number 393224

Device Problem Component Missing (2306)

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

Event Date 11/22/2014

Event Type  Injury  

Event Description

It was reported that upon removal of a md venflon pro safety iv catheter, the catheter was missing and that only 1-2 mm of the catheter remained attached to the iv catheter hub and wings.The patient's left hand and forearm were x-rayed and an ultrasound was done.No foreign bodies were found retained in the patient.As of (b)(6) 2014, the patient was awaiting a ct scan.Of note, it was also reported that the stock of the peripheral iv catheters att he hospital where this incident occurred were inventoried and all appeared to be intact.

Manufacturer Narrative

A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

• Brand Name: BD VENFLON PRO SAFETY IV CARHETER 20 G
• Type of Device: INTRACASCULAR 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: 4335969
• MDR Text Key: 5176592
• Report Number: 2243072-2014-00296
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 393224
• Device Lot Number: 4188360P46
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/03/2014
• Date Manufacturer Received: 11/27/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2014
• 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