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.

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) 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.

Manufacturer Narrative

A device history review was conducted for lot number: 0231288.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, a sample could not be obtained for evaluation and testing, but this lot was treated and received a certificate of conformance for sterility.Unfortunately, without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

• 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
• 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
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• 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 Expiration Date: 10/06/2023
• Device Catalogue Number: 383028
• Device Lot Number: 0231288
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other