MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HGSTAR, 14.5 FR, ST, 23CM, STAND; DIALYSIS CATHETER

Model Number 5833730

Device Problems Fracture (1260); Failure to Advance (2524)

Patient Problem No Patient Involvement (2645)

Event Date 05/12/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: one introducer needle and one guidewire in a guidewire hoop was returned for evaluation.Visual and functional evaluation were performed on the device.The investigation is confirmed for failure to advance as the guidewire was not able to advance into the introducer needle during functional testing.The investigation is confirmed for fracture as multiple cracks were noted on the hub of the introducer needle.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.One electronic video was provided for review.The video shows one guidewire being inserted into the introducer needle.The guidewire appears stuck inside the introducer needle as the guidewire was not visible on the tip of the introducer needle.No other anomalies were noted on the guidewire and needle.Based on the video review, the investigation is confirmed for failure to advance.A definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.(expiry date: 07/2021).

Event Description

It was reported that prior to a dialysis procedure the guidewire allegedly failed to advance through the introducer needle as it became stuck.There was no patient contact.

• Brand Name: HGSTAR, 14.5 FR, ST, 23CM, STAND
• Type of Device: DIALYSIS CATHETER
• 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.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10688711
• MDR Text Key: 211636385
• Report Number: 3006260740-2020-03456
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013409
• UDI-Public: (01)00801741013409
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 5833730
• Device Catalogue Number: 5833730
• Device Lot Number: REDW0202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Date Manufacturer Received: 09/24/2020
• 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