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

Catalog Number 415122

Device Problems Complete Blockage (1094); Crack (1135); Fluid/Blood Leak (1250); Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Type  Injury  

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 # 3: reports five caresite luer access devices cracked in the last two months at the narrowing of the device just below the syringe insertion site.As a result of the leakage, all five of the picc lines were lost because they clotted off.The devices are being connected to a bifuse or trifuse, and the most common fluids running in the lines are tpn, intralipids, antibiotics, ns, and dextrose solutions.The reporter stated they could possibly be over tightening them.

• 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: 5567878
• MDR Text Key: 42383027
• Report Number: 2523676-2016-00159
• 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: Health Professional
• Type of Report: Initial
• Report Date: 08/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 415122
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2014
• 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
• Patient Outcome(s): Required Intervention