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

Catalog Number 415122

Device Problems Crack (1135); Fluid/Blood Leak (1250); Difficult to Remove (1528); Sticking (1597)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).Four used caresite valves, without packaging, were received for evaluation.The caresite valves were received attached to safeline t-port extension sets (ref # nf1330).The male luer of the caresite was connected to the female port of the extension sets.In an attempt to replicate the reported event, the returned sample set-ups (with caresite valves still attached to the extension sets) were tested at 10 psi water pressure.Leakage was observed at the caresite / extension set port connection of all four samples.An attempt was then made to remove the caresite valves from the extension sets.The caresite valves were able to be easily removed from all extension set ports.There was no resistance or "sealing" of the valve noted upon removal of the extension set luer ending.Upon removal of the caresite valves, all four nf1330 extension sets exhibited a vertical crack along the body of the luer lock port.The cracks appeared consistent with applied stress.All four caresite valves were then individually subjected to luer taper, flow, and leakage testing according to specification with acceptable results.There were no leakages observed within the caresite valves.The valves were also viewed under magnification and there was no evidence of any cracks or crazing lines on the caresite valve itself.Based on the results of this investigation, a definitive conclusion could not be made regarding the cause of the reported event.Although the exact cause of the cracking observed on the nf1330 extension set could not be determined, cracking of this nature can often be the result of an excess torque force in combination with over-tightening the connection.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 have been issues of cracking and leaking caresite valves.The valves are leaking a variety of solutions and sealing the valve to the picc line, causing removal and replacement of picc lines in the nicu.The caresite valve is attached to a t-port extension set (ref # nf1330), and the extension set is attached to the picc line.In cases where the valve sealed onto the luer ending, only the extension set had to be replaced instead of replacing the picc line.

• 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: 5916995
• MDR Text Key: 53557521
• Report Number: 2523676-2016-00575
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2016
• 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: T-PORT EXTENSION SET (REF # NF1330)
• Patient Outcome(s): Required Intervention