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

Model Number N/A

Device Problem Break (1069)

Patient Problems Chest Pain (1776); Pain (1994); Foreign Body In Patient (2687)

Event Date 04/25/2021

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redu0827 showed no other similar product complaint(s) from this lot number.

Event Description

It reported that six months ago, the patient received picc implantation on the right upper arm.One month later, the patient was discharged without regular admission for maintenance.On april 24, the patient reported that fluid leakage occurred during infusion outside the hospital, the catheter was broken in the body, and the patient felt chest tightness and discomfort.

• Brand Name: GROSHONG NXT CLEARVUE 4F SL BASIC TRAY
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 11890306
• MDR Text Key: 257193334
• Report Number: 3006260740-2021-02049
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741035272
• UDI-Public: (01)00801741035272
• 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: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 7655405
• Device Lot Number: REDU0827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 05/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2019
• 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: 69 YR