MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER; PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER

Model Number N/A

Device Problems Kinked (1339); Aspiration Issue (2883); Device Operates Differently Than Expected (2913)

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

Event Date 02/07/2017

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 complaint of aspiration difficulty was confirmed and the cause appeared to be use related.The products returned for evaluation was one 4fr s/l groshong nxt clearvue piccs: one used and cut.Gross visual evaluation of the sample confirmed blood and usage residue within the catheter and on the exterior surface.The sample was observed to have been cut near the oversleeve of the connector assembly.The sample would not infuse or aspirate through the luer and connector assembly.The distal connector of the sample was then disassembled and, upon inspection of the underlying catheter, a double kink in the catheter tubing was observed.Massaging and releasing the kinks resulted in proper aspiration and infusion.The double kinks in the sample appeared to be either the result of improper assembly or occurred due to forcing the catheter back into the connector assembly.No potential damage, defect, or deformity due to manufacture of the sample was observed.A lot history review (lhr) of reax1201 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the aspiration function of the catheter was abnormal.No patient harm reported.On 04/19/2017-evaluation found that inability to aspirate was due to catheter kink.

• Brand Name: GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER
• Type of Device: PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR 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. -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: 6554023
• MDR Text Key: 74894162
• Report Number: 3006260740-2017-00583
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741086991
• UDI-Public: (01)00801741086991(17)190331(10)REAX1201
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K034020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/09/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 7617405
• Device Lot Number: REAX1201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/03/2017
• Initial Date FDA Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• 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