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 Coagulation in Device or Device Ingredient (1096)

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Date 11/02/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redn3301 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that: on (b)(6) 2020, the left upper limb picc tube was placed in our department due to postoperative chemotherapy for right breast cancer.Postoperative maintenance and use were standardized.On (b)(6) 2020, the patient developed a fever of 40 degrees and came to our department to be hospitalized.On admission, the extremities color doppler ultrasound showed: after picc tube: thrombosis around the venous catheter is required and the lumen is blocked.The picc tube puncture port of the left upper limb was red, swollen, hot and painful, and there were lumps around.Specialized nursing consultation for static therapy, instructed daily iodophor wet compress picc tube puncture port, sterile dressing change, left upper limb immobilization and no infusion, at the same time, oral warfarin sodium tablets 3mg qd, low molecular heparin sodium injection 4000iu subcutaneously injection q12h and anti-inflammatory treatment.11-4 the left upper limb blood culture tested positive for bacterial lactamase, increasing the use of antibiotics.After treatment, the patient still has repeated fever, lumps around the puncture port, high skin temperature, redness and swelling.

• 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: 11023394
• MDR Text Key: 222010391
• Report Number: 3006260740-2020-20949
• 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: 11/30/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 7617405
• Device Lot Number: REDN3301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2019
• 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