MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. ULTRASITE VALVE NEEDLELESS SYSTEM

Model Number CSU100

Device Problems Leak/Splash (1354); Chemical Spillage (2894)

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

Event Date 02/27/2014

Event Type  malfunction  

Event Description

As reported by the user facility: reports during infusion of bicarb and chemo, leakage occurred at the connection between the huber needle tubing and ultrasite valve causing a chemo spill.The rn manager stated the nurse may not have tightened the ultrasite and it began leaking.

Manufacturer Narrative

This report has been identified as b braun medical inc.(b)(4).One used ultrasite valve, without packaging, was received for eval.The huber needle tubing, that was reported to be connected to the valve, was not returned.No abnormalities or anomalies were visually observed on the ultrasite valve.The valve was then subjected to flow and water pressure (leakage) testing according to specification with acceptable results.There was no leakages observed within the valve or at the luer connectors during the testing time frame.The returned sample met requirements according to specification, and the reported failure could not be reproduced.The reporting facility did indicate that the nurse may not have tightened the ultrasite.It is indicated on the instructions for use (ifu) for the reported product catalog number to "firmly attach injection site to desired connection." no adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.If add'l pertinent info becomes available, a f/u report will be filed.

• Brand Name: ULTRASITE VALVE NEEDLELESS SYSTEM
• Type of Device: ULTRASITE VALVE
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; allentown PA
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 3932251
• MDR Text Key: 18798031
• Report Number: 2523676-2014-00088
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSU100
• Device Catalogue Number: 415110
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2014
• Initial Date FDA Received: 04/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: HUBER NEEDLE TUBING