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

Catalog Number 383083

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 10/12/2020

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 foreign liquid was found in the bd intima-ii" closed iv catheter system.The following information was provided by the initial reporter, translated from (b)(6) to english: "when the nurse was about to re-inject the indwelling needle for the patient, she found coffee colored liquid in the indwelling needle pipe, stopped it immediately, reported it to the armory department, and replaced another indwelling needle.No adverse effects were caused".

Event Description

It was reported that foreign liquid was found in the bd intima-ii¿ closed iv catheter system.The following information was provided by the initial reporter, translated from chinese to english: "when the nurse was about to re-inject the indwelling needle for the patient, she found coffee colored liquid in the indwelling needle pipe, stopped it immediately, reported it to the armory department, and replaced another indwelling needle.No adverse effects were caused".

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 9323921.Our records show that this is the only instance of this issue occurring in this production batch.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.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.H3 other text : see h.10.

• 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: 10827122
• MDR Text Key: 225303621
• Report Number: 3006948883-2020-00732
• 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: 12/15/2020

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: Health Professional
• Device Expiration Date: 12/19/2022
• Device Catalogue Number: 383083
• Device Lot Number: 9323921
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1