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

Catalog Number 383062

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

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/24/2020

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 50 bd intima-ii¿ closed iv catheter systems experienced foreign matter contamination.The following information was provided by the initial reporter: when the nurse checked the indwelling needle before puncture, it was found that a white foreign matter was attached to the core of the needle core and immediately replaced another indwelling needle.In the same way, even the removal of several indwelling needles found foreign objects.The incident caused no harm to the patient.

Event Description

It was reported that 50 bd intima-ii¿ closed iv catheter systems experienced foreign matter contamination.The following information was provided by the initial reporter: when the nurse checked the indwelling needle before puncture, it was found that a white foreign matter was attached to the core of the needle core and immediately replaced another indwelling needle.In the same way, even the removal of several indwelling needles found foreign objects.The incident caused no harm to the patient.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/29/2020.H.6.Investigation: bd received three intima-ii 20 gauge units from lot 9347642 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned units and observed a layer of white substance on the needles.The white substance was inspected under a microscope and was found to be on the root of the needles.It was then placed into a hcfc solution and dissolved.After testing and inspection it was determined that the white substance was left over silicone solution from the manufacturing process.Silicone is used to assist with the manufacturing process and aid with insertion process.It has been tested and determined to be safe for medical use.H3 other text : see h.10.

• Brand Name: BD INTIMA-II CLOSED IV CATHETER SYSTEM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 11182458
• MDR Text Key: 227814038
• Report Number: 3006948883-2021-00113
• 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: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/10/2023
• Device Catalogue Number: 383062
• Device Lot Number: 9347642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1