MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. CARESITE (LAD) SYSTEM; CARESITE LUER ACCESS DEVICE

Catalog Number 415122

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

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Event # 1: reports two valves leaked 5fu chemo medication with two different patients.Both valves were used with a cadd pump.The patients were sent home, and during the night, leakage occurred leading to chemo spills.

Manufacturer Narrative

This reported has been identified as b braun medical inc internal report # (b)(4).Two used caresite valves, without packaging, were received for evaluation.The valves were examined under magnification, and both valves exhibited a crack near the parting line on the female luer lock threads of the molded caresite valve body.The crack started from the top of the valve and extended down to the bottom of the luer threads.Without the involved lot number, a thorough investigation could not be performed.Although a definitive conclusion could not be made regarding the cause of the reported event, cracking of this nature can occur when the product is subjected to aggressive solvents, excessive mechanical stresses, or other various unforeseen circumstances during the clinical application.If additional pertinent information becomes available, a follow-up report will be filed.

• Brand Name: CARESITE (LAD) SYSTEM
• Type of Device: CARESITE LUER ACCESS DEVICE
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; allentown PA
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 4766018
• MDR Text Key: 5788006
• Report Number: 2523676-2015-00165
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 415122
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2015
• 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: CADD PUMP