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	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of rebn1768 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the guide wire had a kink.No other information was provided.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency 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 damaged guidewire is confirmed and was determined to be use related.One 0.038 in.J-tip guidewire in a plastic hoop and one 18 g introducer needle was returned for evaluation.An initial visual observation showed blood residue on the returned samples.The guidewire was observed to be stuck within the introducer needle, and large amount of blood residue was observed within the introducer needle.A slight bend was observed in the guidewire about 42 cm distal to its proximal end.The core wire was observed to be intact during tactile evaluation.A microscopic observation revealed a large amount of blood residue at the needle bevel.More blood residue was found on the section of guidewire that was within the needle cannula, once the guidewire was forcibly removed from the introducer needle.Some damage was observed on the needle bevel.The damage observed on the needle bevel suggests the guidewire was withdrawn through the needle which, combined with a relatively large amount of blood residue, caused it to become stuck.The product ifu states: ¿do not pull back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 or resistance cannot be determined.¿ a lot history review (lhr) of rebn1768 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the guide wire had a kink.No other information was provided.

• 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: 7999745
• Report Number: 3006260740-2018-02998
• Device Sequence Number: 1311942
• Product Code: MPB
• UDI-Device Identifier: 00801741045561
• UDI-Public: (01)00801741045561
• Combination Product (Y/N): N
• PMA/510(K) Number: K030268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019

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: N/A
• Device Catalogue Number: 5593150
• Device Lot Number: REBN1768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/29/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1