MAUDE Adverse Event Report: BD BD VENFLON PRO SAFETY IV CATHETER 20G; INTAVASCULAR CATHETER

Catalog Number 393224

Device Problems Disconnection (1171); Leak/Splash (1354)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 09/09/2014

Event Type  Injury  

Event Description

It is reported that the pt expressed pain related to his bd venflon prosafety iv catheter.The pt's nurse evaluated the iv catheter and found nac1 leaking out of the catheter when it was flushed.The catheter was removed and upon further inspection the nurse found that the cannula had become disconnected.The following day the pt was evaluated by a surgeon and an ultrasound of the patient's hand and wrist was performed.The cannula was found to be retained in the patient at the iv insertion site and the decision was made to leave the retained catheter in place.The pt was discharged from the hospital on (b)(6) 2014.

Manufacturer Narrative

The sample is available for evaluation.Upon receipt of the sample and completion of the investigation, a supplemental report will be submitted.Of note, the user facility reports that there is a possible that the involved patient tampered with the device causing the cannula to have loosened.(b)(4).

• Brand Name: BD VENFLON PRO SAFETY IV CATHETER 20G
• Type of Device: INTAVASCULAR CATHETER
• Manufacturer (Section D): BD; one becton dr.; franklin lakes NJ 07417
• Manufacturer Contact: aaron larson ; one becton dr.; franklin lakes, NJ 07417 ; 8015652406
• MDR Report Key: 4170339
• MDR Text Key: 4874875
• Report Number: 2243072-2014-00200
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 393224
• Device Lot Number: 4114036
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2014
• 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
• Patient Age: 87 YR