MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER

Catalog Number 383028

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 02/16/2021

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd intima-ii" closed iv catheter system was involved with a patient experiencing an infection injury. After device use, the patient was diagnosed with phlebitis and a pus spot was discovered at the indwelling needle site. Antibiotics were administered and a blood analysis test was conducted. The following information was provided by the initial reporter: the patient came to the outpatient department of hospital for infusion on (b)(6) 2021, and the intravenous indwelling needle was placed in the wrist. On (b)(6) 2021, the infusion was not fluent, so the indwelling needle was pulled out. On (b)(6), the child showed high fever and went to hospital again. A pus spot was found at the site of the venous needle of the left wrist, which touched a cord-like hard mass. The doctor diagnosed phlebitis. Local disinfection and wet compress of magnesium sulfate were given. Blood analysis indicated high hemogram, and antibiotics were given symptomatic treatment in hospital.

• Brand Name: BD INTIMA-II CLOSED IV CATHETER SYSTEM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11526787
• MDR Text Key: 247495863
• Report Number: 3006948883-2021-00310
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 383028
• Device Lot Number: 0231288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/19/2021 Patient Sequence Number: 1