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

Catalog Number 415122

Device Problems Crack (1135); Device Slipped (1584)

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.B.Braun has worked closely with (b)(6) and (b)(4) (manufacturer of the bioflo picc) to identify the root cause of the picc line hub cracking.Since this report, several collaborative meetings have been held with (b)(6), b.Braun, and (b)(4) to discuss and observe the specifics around the occurrences.B.Braun and (b)(4) have shared testing protocols and results in an effort to identify the root cause of the issue.B.Braun executed testing of the (b)(4) picc catheter hub when connected to both the caresite valve as well as the ultrasite valve.The testing included lipids exposure between engaged luer faces of the catheter and valves at 2 different torque values.Testing was completed with 24 hrs of engaged lipid exposure.The testing indicated that cracks could occur in the catheter hub when lipids are trapped between luer faces and engaged at higher torque values (4 in-lbs).Picc cracks occurred at similar incidences when either valve was used (caresite or ultrasite).Further testing was completed with a competitive valve which yielded higher cracking incidence in the picc hub.B.Braun shared this data and protocol with (b)(4).During a collaborative meeting at the customer site, (b)(4) communicated that they completed similar testing of their catheter with both ultrasite valve and caresite valve as well as with (b)(4) stopcocks.(b)(4) was able to duplicate the catheter cracking incidences in their testing with both valves and stopcock without distinction.Since testing indicated no correlation to a specific valve, (b)(4) completed further testing of their catheter hub with their stopcock attached to the catheter hub with lipids at the higher torques to better understand the nature of the catheter hub failure.Testing by both b.Braun and (b)(4) indicates that trapping lipids between mating luer faces at higher torques is likely the root cause of the failure rather than as a direct result of the caresite and ultrasite.It was recommended by b.Braun that efforts to minimize trapping tpn / lipids between mating luer faces should be made.A review of the flush sequence for needleless connectors at (b)(6) may help to identify opportunities to minimize the potential for tpn / lipids to be trapped between luer faces.If additional pertinent information becomes available a follow-up report will be filed.

Event Description

As reported by the user facility: reports clinicians are stating that at times the caresite luer access device will continue to rotate once attached to the female hub of a picc line, causing cracking of the picc.The caresite is used on the hubs of bioflow picc lines.The facility also uses curos disinfection caps on the caresite.Additional correspondence received from the reporting facility indicated the picc catheter material has been the same for the last several years.The staff is only experiencing this problem with central lines, not peripheral catheters or extension sets.Both the catheter hub and the male end of the caresite are cracking.The picc team said that 99% of the cracking happens when tpn is being infused.The picc team thinks that the caresite valve is to blame for the cracking.The picc team feels that there is no stop on the threads of caresite, and that the caresite valve will continue to turn down through the hub of the catheter when a nurse uses the curos cap.The picc team feels that the ultrasite valve did stop on the catheter, but caresite continues to turn.The picc teams also feels that the tpn may be a contributing factor to the cracking.

• 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: 5567890
• MDR Text Key: 42424354
• Report Number: 2523676-2016-00162
• 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: 03/23/2015

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: 03/23/2015
• 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