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

Catalog Number 383033

Device Problem Contamination (1120)

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

Event Date 08/08/2018

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 with the use of the bd intima-ii¿ closed iv catheter system there was an issue with foreign matter.There was no report of injury or medical intervention.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.A review of the device history record revealed no irregularities during the manufacture of the reported lot.One sample was returned in an unopened package.There is viible rust on the middle of the needle cover.Samples were received in flks to complete ftir testing on the reddish material observed in the lumen of the cannula.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.No results were acquired from the ftir analysis which indicates that the reddish material is metallic in nature.This material was then prepared for sem/edx analysis.This analysis yields an elemental breakdown of the material.The analysis shows that this material contains iron, chromium, carbon, and nickel, all of which are components of steel.The chlorine and oxygen are most likely from saline.The silicon and carbon are most likely from the silicone that is present on the surface of the cannula.All of this information indicates that the reddish material is rust.Strong oxidizing or humid environment cause product rust, this defect is related to the product transfer subsequent transportation and storage.

Event Description

It was reported with the use of the bd intima-ii closed iv catheter system there was an issue with foreign matter.There was no report of injury or medical intervention.

• 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: 7811089
• MDR Text Key: 118401333
• Report Number: 3006948883-2018-00155
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 09/12/2018

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: No Information
• Device Expiration Date: 02/24/2021
• Device Catalogue Number: 383033
• Device Lot Number: 8017220
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 08/23/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other