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

Catalog Number 415122

Device Problem Chemical Spillage (2894)

Patient Problems Skin Discoloration (2074); Skin Irritation (2076)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.Incidents of cracked/leaking valves can be caused by many factors, including but not limited to an excess torque force in combination with over-tightening the connection; if the product is subjected to aggressive solvents, excessive mechanical stresses, or other various unforeseen circumstances during the clinical application.However without the actual sample or lot number, a thorough sample analysis or batch record review could not be performed and no specific conclusions can be drawn.If additional pertinent information becomes available a follow-up report will be filed.

Event Description

As reported by the user facility: event # 1: reports there were two incidents of chemo leakage.The patients went home with an elastomeric pump (halyard homepump c series) of 5fu.The patients called the infusion center reporting the leaking from the caresite valve.The complaints have happened with 2-day and 7-day infusions.One patient called that he woke up in the middle of the night with his chest being completely wet.When he came to the center it looked like he had frost across his chest from the leaking of the medication.

• Brand Name: CARESITE® (LAD) SYSTEM
• Type of Device: CARESITE LUER ACCESS DEVICE
• 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: 5402057
• MDR Text Key: 37519837
• Report Number: 2523676-2016-00009
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 415122
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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