MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 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 Defective Device (2588)

Patient Problem Thrombus (2101)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

The information provided by bd 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 bd.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redp1423 showed one other similar product complaint(s) from this lot number.Device not returned for evaluation.

Event Description

It was reported, "device use time: 2020-08-04; purpose of use: infusion of chemotherapy drugs; basis for use: according to the national static therapy industry standard, it is pointed out that the use of cytotoxic drugs needs to be infused from a central venous catheter; use conditions: the patient¿s process went smoothly on the day of the catheterization , check that the catheter bolus was not abnormal before intubation, blood could not be withdrawn after catheterization, the result of picc spot film was normal, the position of venography was normal, and the catheter was continued.Adverse events: after the patient received 8 courses of chemotherapy, the catheter was removed, the catheter was checked for integrity, the fluid was withdrawn, and the injection was normal, and the catheter valve was suspected to be abnormal.; impact on the victim: because the blood cannot be retrieved each time, x-ray spot film is required each time, which increases the patient's radiation exposure, increases the patient's extra cost, and increases the workload of the nurse.Time for treatment measures: 2020-08-04; treatment measures: 1.Increase x-ray examination to ensure that the catheter position is normal, 2.Nurses pay more attention to whether the patient has abnormal discomfort.3.Thrombolysis with urokinase.Time for improvement of adverse events: (b)(6) 2020; combined use of equipment: none; no blood returned after catheter placement, normal position: 1.Doubt whether the catheter is three-way valve abnormality? 2.The fibrin sheath at the front end of the catheter is wrapped and the blood cannot be withdrawn.After the catheter was removed, there was no blood return.The inspection of the catheter found: 1.No fibrin sheath was found at the tip of the catheter, 2.The catheter was withdrawn with a syringe and the liquid could not be drawn out.".

• 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): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 11236770
• MDR Text Key: 230033902
• Report Number: 3006260740-2021-00059
• 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
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• 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: REDP1423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• 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): Other