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

Catalog Number 383019

Device Problems Leak/Splash (1354); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2020

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.(b)(4).

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system experienced ruptured tubing and expanded/ballooned tubing.The following information was provided by the initial reporter: the intima-ii had pipe broken.There was a break at the extension tube during ct-enhanced angiography, no patient was injured, no blood leaked, no photo returned, and high-pressure injection was involved, and the customer did not remember the pressure value of the high-pressure high-pressure injection.

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 0168655.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.No actual sample returned, the rupture of extension tubing of the indwelling needle is unknown.No abnormality found on process, the detailed usage pressure was not confirmed.

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system experienced ruptured tubing and expanded/ballooned tubing.The following information was provided by the initial reporter: the intima-ii had pipe broken there was a break at the extension tube during ct-enhanced angiography, no patient was injured, no blood leaked, no photo returned, and high-pressure injection was involved, and the customer did not remember the pressure value of the high-pressure high-pressure injection.

• 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: 10831927
• MDR Text Key: 218589218
• Report Number: 3006948883-2020-00737
• 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: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/19/2023
• Device Catalogue Number: 383019
• Device Lot Number: 0168655
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1