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

Catalog Number 383083

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 12/10/2018

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 y-connection and e-tubing of bd intima-ii¿ closed iv catheter system were loosened and separated.

Event Description

It was reported that y-connection and e-tubing of bd intima-ii¿ closed iv catheter system were loosened and separated.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 8079074.Records show the reported lot was manufactured in april of 2018 and determined that this is the only instance of a leaking tubing being reported 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.Investigation conclusion: during the investigation of the sample submitted by the facility our investigators noted a small crack located on the adapter, discovered through the use of leakage testing.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 the line determined that the machine is in the proper orientation and operating normally.Root cause description: 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 599768 is initiated to address this issue.

• 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: 8204333
• MDR Text Key: 131783959
• Report Number: 3006948883-2018-00320
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830336
• UDI-Public: 382903830336
• 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: 01/16/2019

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: 05/03/2021
• Device Catalogue Number: 383083
• Device Lot Number: 8079074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2018
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 12/10/2018
• Supplement Dates FDA Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other