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 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6).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 it leaked at the y adapter.

Manufacturer Narrative

Investigation summary: a sample was received for the purpose of our investigation.A device history report was conducted for lot number 8198203, and no related abnormalities were found.This lot of intima ii was manufactured in august 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: our investigators noted a small crack was found during leakage testing that was located on the adapter.The returned product's swage dimensions were measured by our team and found to be within product specifications.However according to previous investigations, depending on pressure variance in the autoline's swage pressure it is possible for the machine to become misaligned allowing for the resulting crack to form in the device; a review of our line determined that the machine is in the proper orientation and operating normally.Root cause description: we are 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.

Event Description

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

• 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: 8206374
• MDR Text Key: 131773555
• Report Number: 3006948883-2018-00325
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2021
• Device Catalogue Number: 383078
• Device Lot Number: 8198203
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 12/31/2018
• Supplement Dates Manufacturer Received: 12/11/2018
• Supplement Dates FDA Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other