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U.S. Department of Health and Human Services

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

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BD (SUZHOU) BD INTIMA-II CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER Back to Search Results
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.
 
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Brand NameBD INTIMA-II CLOSED IV CATHETER SYSTEM
Type of DeviceINTERVASCULAR 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 Key11171811
MDR Text Key227077826
Report Number3006948883-2021-00096
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received01/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383019
Device Lot Number9239030
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/27/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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