MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / BIOFLO; PERIPHERALLY INSERTED CENTRAL CATHETER

Catalog Number	H965750121
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Fluid Discharge (2686)
Date of Event	01/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records was performed for the indicated packaging and picc assembly 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 december 2015 angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode "catheter leaked - removed." no adverse trend was identified.No damage or defects were noted on the returned, used catheter.When a 10ml syringe was used to flush the device with cleaning solution, the device flushed easily.A guidewire was then fed through the valve and removed by pulling back through the valve.No obstructions were encountered.When primed and clamped at the distal end, an attempt to inject fluid was unsuccessful, confirming no leakage in the catheter.Dimensional measurements taken of the catheter tip i.D.And o.D.Were found to be within specification.The reported issue was unable to be confirmed, nor can the root cause be determined, as the returned sample was found to be visually and functionally acceptable.Potential contributing factors may include the end user not securing the end cap during routine catheter maintenance or during catheter care as described in the directions for use.Manufacturing process controls for the picc device include 100% visual inspection for molding defects, and a guidewire insertion test to verify lumen patency.In addition, all catheters are 100% leak tested after the guidewire verification.(b)(4).
Event or Problem Description
As reported, picc was remove and replaced 4 days after initial insertion due to leakage (frequent dressing changes) noted at the insertion site.Trouble shooting was performed (flushing with normal saline) and clear fluids were noted coming out from the site.

• Brand Name: ANGIODYNAMICS / BIOFLO
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 5627055
• Report Number: 1317056-2016-00019
• Device Sequence Number: 13465485
• Product Code: LJS
• UDI-Device Identifier: H965750121
• UDI-Public: H965750121
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K131038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: H965750121
• Device Lot Number: 4938599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2016
• Initial Report FDA Received Date: 05/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1