MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON 18G X 45MM IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 391453

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

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Event Description

The catheter broke during removal, leaving a portion of the catheter tubing in the patient's left forearm.Surgical intervention was required to remove the catheter tubing.

Manufacturer Narrative

It is uncertain at this time if the sample is available for evaluation.If additional information or the sample is received, a supplemental report will be submitted.Pir# (b)(4).

• Brand Name: BD VENFLON 18G X 45MM IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton dr.; franklin lakes NJ 07417 188
• Manufacturer Contact: amy bodell ; 1 becton dr.; franklin lakes, NJ 07417-1880 ; 8015652585
• MDR Report Key: 4017359
• MDR Text Key: 4712636
• Report Number: 2243072-2014-00170
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 391453
• Device Lot Number: 13H1341L
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2013
• 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