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 Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Thrombus (2101); Chills (2191)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redt4250 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that this patient had a picc catheter placed on (b)(6) 2020 due to the infusion session longer than 2 weeks.On (b)(6) 2020, this patient developed fever, and swelling and pain with the soft tissue at the picc insertion site in the right upper arm, with the temperature reaching up to 38.9, and chill.It was suspected that this might be caused by skin soft tissue infection at the insertion site or possible septicemia.Ultrasound suggested venous thrombus in the right basilic vein.Administered ceftriaxone and piperacillin and tazobactam for anti-infection, acetaminophen for fever abatement, and low molecular weight heparin sodium for anti-coagulation, without other device used in combination.

• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 10494601
• MDR Text Key: 205690672
• Report Number: 3006260740-2020-03172
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741086991
• UDI-Public: (01)00801741086991
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K034020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 7617405
• Device Lot Number: REDT4250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR