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

Catalog Number 383426

Device Problems Leak/Splash (1354); Device Fell (4014)

Patient Problem No Information (3190)

Event Date 01/20/2019

Event Type  malfunction  

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 when "iohexanol" was injected with the bd intima-ii¿ closed iv catheter system from a high-pressure pump during the patient's ct examination, the prn stopper fell off and caused some of the medication not to be "pushed" into the body, as well as some of it to leak from the needle.As reported by the customer, translated from (b)(6) to english, "1-20 nurses accompanied patients with ct examination.When iohexanol injection was injected intravenously with high-pressure pump, the rubber stopper of prn fell off, which resulted in part of the liquid not pushed into the human body and a little liquid overflowed from needle.Md registration certificate# (b)(6)".

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 8043490.Our records show that this is the only instance of this issue occurring in this batch of intima ii.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.Unfortunately a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system leaked from the septum while being used on a patient for "preoperative preparation".As reported by the customer, per google translate, "the operating room nurse performs the puncture indwelling needle when preparing the patient for preoperative preparation.The needle core is accompanied by blood back leakage, the obstruction cannot function, causing blood leakage, the nurse immediately performs the hemostasis operation, and replaces another closed type.Intravenous indwelling needle, successful puncture.And reported to the procurement center, when the device was inspected, the blockage was found to be blood stains, and the blockage could not prevent blood from flowing back.National machinery note (b)(4).".

• 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: 8418370
• MDR Text Key: 141048092
• Report Number: 3006948883-2019-00174
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2021
• Device Catalogue Number: 383426
• Device Lot Number: 8043490
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other