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

Catalog Number 383083

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

Patient Problems Bruise/Contusion (1754); Phlebitis (2004)

Event Date 11/27/2020

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.(b)(4).

Event Description

It was reported that the patient developed phlebitis when the bd intima-ii" closed iv catheter system was used on them, and the doctor ordered an external phenitis powder application treatment as a result.The following information was provided by the initial reporter, translated from (b)(6) to english: "at 8:28 in the morning, the patient punctured the indwelling needle for infusion treatment.After 15:37 in the afternoon, the skin appeared bruised.The doctor was notified and the doctor ordered phenitis powder external application treatment." "go to the hospital to communicate with the head nurse.No blunt needle or burr on the needle was found during use.The sample has been lost.Consider the chemical phlebitis caused by the disinfectant before it is dry".

Manufacturer Narrative

H6: investigation summary.A device history review was conducted for lot number 9298431.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.H3 other text : see h10.

Event Description

It was reported that the patient developed phlebitis when the bd intima-ii¿ closed iv catheter system was used on them, and the doctor ordered an external phenitis powder application treatment as a result.The following information was provided by the initial reporter, translated from chinese to english: "at 8:28 in the morning, the patient punctured the indwelling needle for infusion treatment.After 15:37 in the afternoon, the skin appeared bruised.The doctor was notified and the doctor ordered phenitis powder external application treatment." "go to the hospital to communicate with the head nurse.No blunt needle or burr on the needle was found during use.The sample has been lost.Consider the chemical phlebitis caused by the disinfectant before it is dry.".

• Brand Name: BD INTIMA-II CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 11098291
• MDR Text Key: 224860265
• Report Number: 3006948883-2020-01069
• 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: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2022
• Device Catalogue Number: 383083
• Device Lot Number: 9298431
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention