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

(b)(6).(b)(4).Investigation summary: in response to the event reported by your facility a device history review was conducted for lot number 9239030.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 samples 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.Investigation conclusion: there was visible silicon oil particle in the needle.No actual sample returned.The returned photos also showed silicone oil residue on the surface of the needle.Needle silicone oil investigation: according to the characteristics of silicone, during the high temperature and humidity , there may be a little precipitate on the needle.Bd's materials laboratory in the united states conducts a normative test on the silicone used in the product process.The test results show that the silicone is a lubricant for medical device products and meets the requirements of relevant iso and fda standards.Check the batch record, record of in-process inspection and final inspection.No fining on residual of silicone on the needle.The silicone is a lubricant for medical device products ,the substance is non-toxic and harmless meets the requirements of relevant iso and fda standards.The factory will continue to monitor such defect.

Event Description

It was reported that 168 bd intima-ii" closed iv catheter systems experienced foreign matter contamination.The following information was provided by the initial reporter: there was visible sillicon oil particle in the needle.The problem occurred in the psychiatric department.

• 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
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11171811
• MDR Text Key: 227077826
• Report Number: 3006948883-2021-00096
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/26/2022
• Device Catalogue Number: 383019
• Device Lot Number: 9239030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1