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 Material Frayed (1262)

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

Event Date 09/11/2018

Event Type  malfunction  

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 difficulties passing a guidewire through an introducer needle is confirmed and was determined to be use related.One 0.038 in.J-tip guidewire in a dispenser hoop, one 18 g introducer needle, one 20 cm niagara catheter with a stiffening stylet inserted, one 13 fr dilator, one 14 fr dilator, one attachable suture wing, and two silicone end caps were returned for evaluation.An initial visual observation showed blood residue on the introducer needle, guidewire, catheter, 14 fr dilator, and attachable suture wing.The coiled wire of the guidewire was observed to be unraveled and the core wire was observed to be broken.Multiple bends were observed in the guidewire.A microscopic observation revealed the needle bevel was damaged.The break site of the core wire was observed to be tapered with a granular surface texture.The location and characteristics of the break in the guidewire and the damage observed on the needle bevel suggest the guidewire was withdrawn against the needle bevel, which caused it to become stuck and, ultimately, break due to excessive tensile force.The product ifu cautions: ¿do not pull back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.¿ 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 the guide has difficulty passing through the needle and when maneuvering it gets stuck making it difficult to use so they decide to remove it.On (b)(6) 2018 - the returned wire is frayed.

• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: heather murphy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225738
• MDR Report Key: 8026508
• MDR Text Key: 125936909
• Report Number: 3006260740-2018-03057
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K030268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1