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

Catalog Number 383078

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2018

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 during use of the bd intima-ii¿ closed iv catheter system leaked.

Manufacturer Narrative

Investigation summary: a sample was received for the purpose of our investigation.A device history report was conducted for lot number 8107025, and no related abnormalities were found.This lot of intima ii was manufactured in july of 2018; bd engineers have noted a trend in leakage for this lot.According to the sampling plan applied for product performance, this lot was accepted and released, with no defects being noted during final assembly or visual inspections.Investigation conclusion: the investigators were able to observe the reported failure mode in the sample provided.A small cracked was found during leakage testing and was located on the adapter.The returned product's parameters for swage dimension and swage length were tested and found to be within product specifications.Root cause description: depending on pressure variance in the auto line's swage pressure, it is possible for the machine to become misaligned allowing for the resulting crack to form in the device.Bd is currently conducting a long term study to determine the root cause for this event.Rationale: bd will continue to track and trend for this issue.Capa # 642738 has been initiated to address this issue.

Event Description

It was reported that during use of the bd intima-ii¿ closed iv catheter system leaked.

• 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: 8206719
• MDR Text Key: 131913150
• Report Number: 3006948883-2018-00328
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830787
• UDI-Public: 382903830787
• 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: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2021
• Device Catalogue Number: 383078
• Device Lot Number: 8107025
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other