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

Catalog Number 383014

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Code Available (3191)

Event Date 11/24/2019

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 patient removed the bd intima-ii¿ closed iv catheter system needle due to being "confused".The nurse discovered this and reported to the doctor, where a consultation was done with the surgeon.A "local incision exploration" and "2 stitches" were conducted after, but nothing was found.The following day, the patient received a consultation with the vascular intervention department, and received a complete chest radiograph, but again, nothing was found.The following information was provided by the initial reporter, translated from (b)(6) to english: "on (b)(6) 2019, the patient was in confusion and removed the indwelling needle by himself.The nurse found that the needle was broken and the stump was not found.Report to the doctor immediately, conduct local incision exploration after consultation with the surgeon, and suture 2 stitches if no findings are found.On the second day, the patient received a consultation with the vascular interventional department, and received a complete chest radiograph.".

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number: 8325583.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.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 patient removed the bd intima-ii¿ closed iv catheter system needle due to being "confused".The nurse discovered this and reported to the doctor, where a consultation was done with the surgeon.A "local incision exploration" and "2 stitches" were conducted after, but nothing was found.The following day, the patient received a consultation with the vascular intervention department, and received a complete chest radiograph, but again, nothing was found.The following information was provided by the initial reporter, translated from chinese to english: "on (b)(6) 2019, the patient was in confusion and removed the indwelling needle by himself.The nurse found that the needle was broken and the stump was not found.Report to the doctor immediately, conduct local incision exploration after consultation with the surgeon, and suture 2 stitches if no findings are found.On the second day, the patient received a consultation with the vascular interventional department, and received a complete chest radiograph".

• 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: 9474653
• MDR Text Key: 182211655
• Report Number: 3006948883-2019-01090
• 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: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2021
• Device Catalogue Number: 383014
• Device Lot Number: 8325583
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention