MAUDE Adverse Event Report: NAVILYST MEDICAL NAVILYST MEDICAL / XCELA; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number H965251010

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Unspecified Infection (1930)

Event Date 02/26/2014

Event Type  Injury  

Event Description

Per user medwatch (b)(4) forwarded to navilyst medical from the (b)(4), the event description is: "multiple reports of patients with this particular picc line where fluid is noted to be leaking.On closer inspection two reported as 'lumen leaking' one reported as 'both ports cracked.' picc lines required replacement.Reported that these leaks may have contributed to blood stream infections.Reported to vendor by nursing products department and now new vendor is being used for picc lines." the used device referenced in the user medwatch is not being returned to navilyst medical.

Manufacturer Narrative

The investigation into this event is still ongoing.Navilyst medical has made, and is continuing to make inquiries of the hospital to determine if the issue of "blood stream infections" actually occurred or is being stated as a potential concern.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).

Manufacturer Narrative

A review of the device history records was performed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The (b)(4) june 2015 complaint report was reviewed for the bioflo picc product family and the failure mode "hub extension tubing cracked/detached." no adverse trends were indicated.Returned for evaluation was a non-valved bioflo picc, not an xcela picc, as originally reported.The extension tube with the white clamp was confirmed to have a fracture at the molded luer-to-hub interface.The fracture was approximately 1/2 of the circumference of the hub.No molding-related non-conformances were noted, e.G., no sink marks, short shots or heat damage.The hub-to-extension tubing junction was measured and found to meet id specification.Additionally, the tubing was cross-sectioned, measured, and found to meet id and od specifications and not show any wall thickness abnormalities.Although a definitive root cause for the failure is unable to be determined, a potential root cause is believed to be erosion of the tubing due to prolonged exposure to alcohol and/or a similar cleansing agent.Extended chemical exposure may weaken the tubing-to-hub joint and make it more susceptible to fracture during handling of the hub/extension tubing during picc access.A contributing factor may also be excessive twisting of the hub-to-extension tubing joint during site cleansing.It was unable to be confirmed with the hospital if there were actual blood stream infections as a result of the extension tubing fracture.This may have been a potential concern, not an actual event.In addition, the medwatch form identified an xcela picc as the device in question but a bioflo picc was returned for evaluation.No clarification from the hospital was received.Manufacturing process controls for the picc device includes a 100% visual inspection of the tubing/luer interface, tensile testing of the molded luer-to-tube connection, a guidewire insertion test for lumen patency, and 100% leak testing.

• Brand Name: NAVILYST MEDICAL / XCELA
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): NAVILYST MEDICAL ; glens falls NY
• Manufacturer (Section G): NAVILYST MEDICAL ; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: michael duerr ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424571
• MDR Report Key: 3820057
• MDR Text Key: 16084805
• Report Number: 1317056-2014-00024
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Catalogue Number: H965251010
• Device Lot Number: 4570473
• Other Device ID Number: XCELA PICC
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/01/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• 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