MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. ULTRASITE® VALVE NEEDLELESS SYSTEM; SMALL BORE EXTENSION SET WITH ULTRASITE INJECTION SITE

Model Number CSE6L

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample, a thorough sample analysis could not be performed and no specific conclusions could be drawn.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.If additional pertinent information becomes available or if the physical sample is received for evaluation, a follow-up report will be filed.

Event Description

As reported by the user facility: event # 2: reports after opening the package, the nurses tighten the set and connect it to the patient.After the iv was connected and running, the patient noticed the drug leaking through and around the extension set, wetting the patient's arm and spilling on the floor.When leakage is noted, the infusion is stopped, the area cleaned, the iv catheter flushed, and the hub retightened and taped over to keep it on tight.A variety of medications have leaked, including chemotherapy medication.

• Brand Name: ULTRASITE® VALVE NEEDLELESS SYSTEM
• Type of Device: SMALL BORE EXTENSION SET WITH ULTRASITE INJECTION SITE
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 5947340
• MDR Text Key: 54949144
• Report Number: 2523676-2016-00596
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K760385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/18/2016

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 Expiration Date: 04/30/2021
• Device Model Number: CSE6L
• Device Catalogue Number: 473438
• Device Lot Number: 0061503580
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2016
• 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