MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Extravasation (1842)

Event Date 07/07/2022

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redx0976 showed one other similar product complaint(s) from this lot number.

Event Description

It was reported on (b)(6) 2022, the catheter was placed by a professional nurse, and the process went smoothly.After filming, the catheter was shown to be in a normal position after implantation.On july 7th, the doctor ordered systemic chemotherapy.Before the infusion at 09:00, check the position of the puncture site, there is no exudate, and the blood return is smooth; when the shift is at noon, it is checked, the position is smooth, and there is no exudate in the puncture.Entering chemotherapy drugs, when the shift was handed over at 14:00 in the afternoon, the pipeline was in place, and the puncture site was dry and there was no exudate.The infusion went smoothly; at 15:45, when the nurses visited the puncture site, they saw exudate at the puncture site and immediately stopped the infusion.The static therapy group consulted and instructed the nurses to withdraw the catheter by 2 cm and perform flushing test.When flushing the tube, it was found that there were cracks and fluid leakage at 36-37 cm.Because the fluid exuded by the patient is a chemotherapy drug, the nurse has dealt with it in time.It is not ruled out that there may be local necrosis in the later stage.The patient has been extubated according to the doctor's order, and the patient was discharged from the hospital on july 8.

• Brand Name: GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15254736
• MDR Text Key: 298198229
• Report Number: 3006260740-2022-03209
• 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: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 7617405
• Device Lot Number: REDX0976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2019
• 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