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 Bacterial Infection (1735); Purulent Discharge (1812)

Event Date 01/04/2019

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible; the manufacturing lot number that was provided is incorrect.

Event Description

It was reported that a large amount of yellowish white purulent secretions were seen around the catheter, and the patient's body temperatures rose repeatedly.The patient had a picc catheter placed on (b)(6) 2018, and dressing for the picc was scheduled for changing on (b)(6) 2019.The patient did not return to the hospital for dressing change on time.At that time, a little secretion was seen around the catheter.During dressing change on (b)(6) 2019 in the hospital, a large amount of yellow-white purulent secretions were observed around the catheter.Staphylococcus aureus was cultured from the purulent secretions and intraductal blood.The patient was given levofloxacin injection during hospital stay on (b)(6) 2019.After the anti-infection treatment with single-drug, the patient suffered from fever repeatedly, with the body temperature reaching up to 39 ° c.Any fever did not occur any more after the anti-infection treatment with the addition of cefoperazone sulbactam from (b)(6) 2019.

• 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: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 8916654
• MDR Text Key: 155091197
• Report Number: 3006260740-2019-02423
• 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: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• 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: REBY-0736 (INVALID)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 07/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 67 YR