MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II Y 20GAX1.16IN PRN/EC SLM; INTRAVASCULAR CATHETER

Catalog Number 383012

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

Patient Problem No Patient Involvement (2645)

Event Date 10/30/2020

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 13 intima-ii y 20gax1.16in prn/ec slm catheters were found with foreign lubricant on their needles.The following information was provided by the initial reporter, translated from (b)(6) to english: staff of the equipment department found that there was a solid suspected of lubricant at the tip of the needle.Subsequent sampling inspection showed the same problem, with a total number of about 800.There are 13 in the hands, which have been photographed.The solid composition needs to be investigated, and needs to be proven to be harmless to human.

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 9050849.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 photographs 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.H3 other text : see h.10.

Event Description

It was reported that 13 intima-ii y 20gax1.16in prn/ec slm catheters were found with foreign lubricant on their needles.The following information was provided by the initial reporter, translated from chinese to english: "staff of the equipment department found that there was a solid suspected of lubricant at the tip of the needle.Subsequent sampling inspection showed the same problem, with a total number of about 800.There are 13 in the hands, which have been photographed.The solid composition needs to be investigated and it needs to be proven to be harmless to human.".

• Brand Name: INTIMA-II Y 20GAX1.16IN PRN/EC SLM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 10902114
• MDR Text Key: 218989772
• Report Number: 3006948883-2020-00837
• 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: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/06/2022
• Device Catalogue Number: 383012
• Device Lot Number: 9050849
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1