MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problems Obstruction of Flow (2423); No Flow (2991)

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

Event Date 04/18/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of recv2779 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the patient diagnosed with brain tumor was admitted to hospital for treatment.After hospitalization, the relevant examinations were improved and picc insertion was planned.A 7617405 catheter was selected and the insertion process went smoothly.No abnormalities occurred during guidewire removal and tail end trimming conducted after the catheter was delivered to the target location.When installing the oversleeve portion of connector, the operator felt it did not go smoothly, a sense different from the normal.It was difficult to connect the metal handle to the catheter in the process of extension tube installation.It was suspected this may be caused by the gloves worn.The connection succeeded after several adjustments were attempted.However, blood could not be drawn and normal saline could not be injected.Still failed after several adjustments.Given that the catheter had been inserted in the patient's body, it was decided to remain the original catheter unchanged, but replace the extension tube with a new one.After the exchange, blood could be drawn and normal saline could be injected.

• Brand Name: GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 8656526
• MDR Text Key: 146914860
• Report Number: 3006260740-2019-01513
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741086991
• UDI-Public: (01)00801741086991
• Combination Product (y/n): N
• 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: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• 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: 7617405
• Device Lot Number: RECV2779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• 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