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

Catalog Number 393226

Device Problem Detachment Of Device Component (1104)

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

Event Date 02/21/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the reporter stated that when the peripheral vascular catheter was discontinued from the patient at discharge.The catheter loosened from the catheter hub and catheter went into the patient.The catheter could be identified in the vena jugulars and was removed ater six days.It was unclear whether the peripheral vascular catheter was pre-hospital or in the emergency department.Add'l info rec'd via e-mail on (b)(6) 2014, the reporter stated that the patient experienced an ultrasound.The peripheral vascular catheter was removed in surgery by a vascular surgeon, with local anesthesia.The patient has been okay both before and after the incident.

Manufacturer Narrative

No samples or photos were returned therefore the complaint could not be confirmed and the root cause is undetermined.Unable to run complaint history check or device history review as lot number is unknown.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.

• Brand Name: BD VENFLON PRO SAFETY PERIPHERAL SAFETY
• Type of Device: IV CATHETER
• Manufacturer (Section D): BD; 1 becton dr.; franklin lakes NJ 07417
• Manufacturer (Section G): BD SINGAPORE BRANCH; 30 tuas avenue 2; 6394 61
• Manufacturer Contact: elizabeth closner, rn, bsn ; 1 becton dr.; franklin lakes, NJ 07417 ; 2105265165
• MDR Report Key: 3769983
• MDR Text Key: 4379638
• Report Number: 2243072-2014-00067
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 04/04/2014

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: 393226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/24/2014
• Initial Date FDA Received: 04/07/2014
• 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