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

Catalog Number 393224

Device Problem Material Fragmentation (1261)

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

Event Type  Injury  

Event Description

Pt attended for a contrast enhanced mr examination.The cannula was inserted into the pt's antecubital fossa as per trust's cannulation policy.The cannula was flushed with 10mls of saline with no issues.The mr contrast was administered during the scan with no issues.Upon removal of the cannula, only part of the cannula came out; the other part remained in the pt's arm.The pt was asked to remain in the department and pressure was applied to the department manager and the consultant radiologist on call, who carried out an ultrasound examination to find the remaining portion of the cannula.One found, it was marked on the pt's skin with permanent marker.The pt was urgently referred to the vascular team.The vascular team admitted him to the (b)(6) hospital where the portion of cannula was removed under local anaesthetic and the pt was discharged home.

Manufacturer Narrative

Results - one used unit was received for eval.Visual inspection of the returned unit confirmed the catheter was broken.A review of the device history records revealed on irregularities during the mfr of reported lot number 3331100.Conclusions: an absolute root cause for this incident could not be identified, however, the engineer concludes that the catheter may have been cut by a sharp object during use.(b)(4).

• Brand Name: BD VENFLON PRO SAFETY IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD; one becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 1 becton dr.; franklin lakes, NJ 07417 ; 8015652341
• MDR Report Key: 3786995
• MDR Text Key: 4432429
• Report Number: 2243072-2014-00057
• 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: Foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/23/2014

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: 11/30/2016
• Device Catalogue Number: 393224
• Device Lot Number: 3331100
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/08/2014
• Initial Date Manufacturer Received: 03/25/2014
• Initial Date FDA Received: 04/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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