MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. INTIMA-II Y 22GAX1.00IN PRN/EC SLM; INTRAVASCULAR CATHETER

Catalog Number 383019

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

Patient Problem No Patient Involvement (2645)

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 97 intima-ii y 22gax1.00in prn/ec slm contained foreign matter.The following information was provided by the initial reporter: "there was visible silicon oil particle in the needle green claims are required.The problem occurred in the internal medicine department.".

Event Description

It was reported that 97 intima-ii y 22gax1.00in prn/ec slm contained foreign matter.The following information was provided by the initial reporter: "there was visible sillicon oil particle in the needle green claims are required.The problem occurred in the internal medicine department.".

Manufacturer Narrative

H6: investigation summary: a device history review was conducted for lot number 0168642.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.Additionally, visual evaluation of the submitted photos and the resulting review of the manufacturing process determined that the identity of the material is solidified silicone.Silicone is a material used to manufacture this device, and is applied to the catheter as a lubricant for reduced resistance during insertion.Excess application of the lubricant is currently possible due to limitations in the manufacturing process.Bd is currently investigating potential process changes to eliminate the occurrence of similar events.H3 other text: see h10.

• Brand Name: INTIMA-II Y 22GAX1.00IN PRN/EC SLM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• MDR Report Key: 11168152
• MDR Text Key: 227093716
• Report Number: 3006948883-2021-00083
• 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: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/26/2023
• Device Catalogue Number: 383019
• Device Lot Number: 0168642
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1