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

Model Number 5594150

Device Problems Unraveled Material (1664); Cut In Material (2454); Difficult to Advance (2920)

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

Event Date 03/26/2018

Event Type  malfunction  

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 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 damaged guidewire was confirmed and the cause appeared to be use related.One 20cm pre-curved niagara catheter was returned for investigation.The implicated product was a 24cm straight niagara catheter.It was reported that another dialysis catheter was used for the catheterization since the guidewire was damaged, and the returned catheter may have been from the 2nd kit.Additional information was requested to determine the reason for the discrepancy between the implicated and returned product.If additional information is obtained, the complaint record will be updated.One guidewire were returned for investigation.The guidewire was received in two segments.The guidewire was severed 61cm from the proximal tip.The adjoining ends of the guidewire exhibited striations in a portion of the core wire cross section, which are indicative of a sharp instrument cut.What appeared to be blood residue was observed on the external surface of the guidewire.The distal segment of the guidewire, which contained the j-tip, was approximately 12cm in length.The proximal 6.5cm section of the distal coil wire segment remained tightly coiled.The coil wire was unraveled and stretched over the core wire distal to this section.The distal tip of the core wire broke at the distal weld tip, which allowed the coil wire to stretch over the core wire.The outside diameter of the guidewire was within specification.The guidewire was able to pass through the niagara stylet.The 18g introducer needle was not returned for investigation.Normal movement of the guidewire is away from the sharpened bevel and will not damage the wire.If the guidewire direction is reversed, the guidewire is then pulled against the sharpened edge of the needle bevel and can cause shearing damage of the wire and/or cause the wire to become stuck within the needle.One of the cautions in 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.¿ a lot history review (lhr) of rebn1626 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the guide wire was stuck and couldn't pass smoothly.On 06/07/2018 - sample evaluation revealed the wire was received in two segments and appears to have been severed with some unraveling of the coil wire.

• Brand Name: NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM (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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7648808
• MDR Text Key: 112850525
• Report Number: 3006260740-2018-01535
• Device Sequence Number: 0
• Product Code: MPB
• Reporter Country Code: CH
• PMA/PMN Number: K090102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5594150
• Device Catalogue Number: 5594150
• Device Lot Number: REBN1626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0