MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM (SHORT-TERM) (DUAL-LUMEN); CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	5593150
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was report that a patient was receiving crrt, with a prismaflex circuit ,through the niagara double lumen catheter.The catheter was apparently in the right internal jugular site.The crrt machine allegedly started drawing in air at the access site.The nurse checked the connection of the crrt set, all tubing, and the connection at the site of the catheter.It was stated that the machine continued to draw in air through the access site.The nurse replaced the crrt set and examined the set for any connection issues or fault in the tubing.No alleged faults were found, no connections appeared faulty.Crrt was restarted, and ran smoothly for approx.15 minutes, when air started to be drawn in from the access, at the lumen of the catheter.The nurse allegedly observed air bubbling coming from inside the catheter.The crrt treatment had to be stopped and the niagara catheter was removed.On 11-apr-18 additional information: there was no injury to the patient as the nurse acted to prevent any injury.The air was captured by the aeration chamber in the crrt tubing.Further air entered the system and crrt was discontinued.The catheter was removed.No replacement was done.The patient¿s crrt treatment was ended.

• Brand Name: NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM (SHORT-TERM) (DUAL-LUMEN)
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7467278
• Report Number: 3006260740-2018-00826
• Device Sequence Number: 13495882
• Product Code: MPB
• UDI-Device Identifier: 00801741045561
• UDI-Public: (01)00801741045561
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K030268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2018

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 Model Number: 5593150
• Device Catalogue Number: 5593150
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1