MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NIAGARA SLIM-CATH DIALYSIS CATHETER 12F X 24CM (STRAIGHT) (SHORT-TERM) (DUAL-LUM; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking dialysis catheter was inconclusive due to the nature of the returned sample.The product returned for evaluation was two photographs which depicted a 24cm niagara slim-cath dialysis catheter.The depicted portion of the device included both luer adapters, extension tubes and the molded joint.Usage residues were evident in both photographs.Both clamps were engaged.No leaking or evidence of device damage was discernible during inspection of the submitted photographs; however, device functionality could not be assessed.Consequently this complaint is inconclusive at this time.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 reported that during crrt initiation micro air bubbles were noted in the aeration chamber immediately following start of crrt as well as air bubbles noted from the access catheter throughout circuit.They changed the filter three times and the crrt machine once to rule out filter or machine problem.The air bubble issue allegedly continued so they were questioning a line crack.The line was removed and a new one placed.

• Brand Name: NIAGARA SLIM-CATH DIALYSIS CATHETER 12F X 24CM (STRAIGHT) (SHORT-TERM) (DUAL-LUM
• 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: 9199595
• Report Number: 3006260740-2019-03059
• Device Sequence Number: 2589507
• Product Code: MPB
• UDI-Device Identifier: 00801741041839
• UDI-Public: (01)00801741041839
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K010778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 5551240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1