MAUDE Adverse Event Report: BD BD VENFLON PRO SAFETY 20G X 32MM IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 393224

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Exposure to Body Fluids (1745)

Event Date 05/21/2014

Event Type  Injury  

Event Description

The involved pt was in the icu and had bad veins.There were no problems when the device was inserted and good blood reflux was observed.When the clinician tried to remove the cannula, she felt resistance.Due to the pt's poor veins, the operator didn't want to risk a new puncture.She fixed the wing of the device with her thumb and pulled harder to remove the cannula.The cannula came out with a flip and the operator observed that the connection between the cannula and the white safety cover was abrupt; the safety was not at the canula tip, but only loose on the canula.Due to the failure, the clinician received a needlestick on her thumb.It is confirmed that there was no infection and the blood of the pt was controlled.The clinician involved was medicated according to the hosp policy.

Manufacturer Narrative

The sample has been received and is currently being evaluated.Upon completion of the investigation, a supplemental report will be submitted.

• Brand Name: BD VENFLON PRO SAFETY 20G X 32MM IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD; 1 becton dr.; franklin lakes NJ 07417
• Manufacturer Contact: amy bodell ; 1 becton dr.; franklin lakes, NJ 07417 ; 8015652585
• MDR Report Key: 3889153
• MDR Text Key: 18544569
• Report Number: 2243072-2014-00126
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/13/2014

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: 393224
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/26/2014
• Initial Date Manufacturer Received: 05/21/2014
• Initial Date FDA Received: 06/13/2014
• Was Device Evaluated by Manufacturer?: No
• 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