MAUDE Adverse Event Report: B. BRAUN OF DOMINICAN REPUBLIC CARESITE EXTENSION SET; IV EXTENSION SET WITH CARESITE

Model Number ET08US

Device Problems Fluid/Blood Leak (1250); Chemical Spillage (2894)

Patient Problem Chemical Exposure (2570)

Event Type  malfunction  

Event Description

As reported by the user facility: event #1 - reports two incidents of chemo spills due to leakages at the backcheck valve.Both occurred on the bone marrow transplant unit.The first incident, a small amount (< 20ml) of rituxan leaked from the reflux port.The tubing was replaced and the infusion restarted.The second incident, the nurse entered the pt room at 18:30 on (b)(6) 2014 and noticed a slow drip on the floor from the circular piece that is part of the iv piggyback tubing set.The drip was steady and continuous.The entire bag of etoposide was empty.

Manufacturer Narrative

This report has been identified as b braun medical inc., (b)(4).The actual device involved in the reported incident was not returned for eval.Without the actual sample, a thorough eval could not be performed and no specific conclusions can 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.There were no other reports of this nature against the reported lot number.If a physical sample is received or if add'l pertinent info becomes available, a f/u report will be filed.

• Brand Name: CARESITE EXTENSION SET
• Type of Device: IV EXTENSION SET WITH CARESITE
• Manufacturer (Section D): B. BRAUN OF DOMINICAN REPUBLIC; santo domingo ; DR
• Manufacturer Contact: eric roden ; km. 22, autopista las americas; las americas industrial park; santo domingo ; DR ; 5491000
• MDR Report Key: 4544447
• MDR Text Key: 15963820
• Report Number: 9614279-2015-00003
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/20/2015

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: 09/30/2017
• Device Model Number: ET08US
• Device Catalogue Number: 474912
• Device Lot Number: 0061399788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2015
• Initial Date FDA Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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