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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.
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Manufacturer (Section D)
901 marcon blvd.
allentown PA 18109
Manufacturer Contact
robert hubert
901 marcon blvd.
allentown, PA 18109
MDR Report Key5567890
MDR Text Key42424354
Report Number2523676-2016-00162
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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 Received04/11/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number415122
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2015
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 Treatment Data
Date Received: 04/11/2016 Patient Sequence Number: 1