MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NIAGARA DIALYSIS CATHETER KIT 13.5F X 20CM (PRE-CURVED) (SHORT-TERM) (DUAL-LUMEN; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that: the guide has difficulty passing through the needle while handling it and gets stuck making it difficult to use, so they decide to remove it.Another device was used.

Event Description

It was reported that: the guide has difficulty passing through the needle while handling it and gets stuck making it difficult to use, so they decide to remove it.Another device was used.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a damage guidewire is confirmed to be use related.One 20 cm niagara catheter,an introducer needle, two dualator dilators, and a guidewire were returned within non-bard dialysis packaging.Usage residue was present on the guidewire and needle.The guidewire was observed to be frayed and the core wire was extending out of the coils.Microscopic observation of the core wire revealed the weld tip to be present on the distal end of the core wire.Microscopic observation of the needle bevel revealed material damage which was likely caused by retraction of the guidewire against the needle bevel.The outer diameter of the guidewire was measured and found to be within specification.Biological residue was observed to be surrounding the guidewire near the j tip which may have contributed to resistance during advancement.Since the guidewire was observed to be frayed and material damage was present on the needle bevel, the complaint is confirmed to be use related.The ifu states "do not pull back guidewire over needle bevel as this may sever the end of the guidewire.The introducer needle must be removed first.Also, if unusual resistance is met during manipulation of the guidewire, discontinue the procedure and determine the cause of resistance before proceeding.Withdraw needle and guidewire if cause of resistance cannot be determined.".

• Brand Name: NIAGARA DIALYSIS CATHETER KIT 13.5F X 20CM (PRE-CURVED) (SHORT-TERM) (DUAL-LUMEN
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8067023
• MDR Text Key: 127206730
• Report Number: 3006260740-2018-03208
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741045615
• UDI-Public: (01)00801741045615
• Combination Product (y/n): N
• PMA/PMN Number: K030268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 5594200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Event Location: Hospital
• Date Manufacturer Received: 11/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1