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U.S. Department of Health and Human Services

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

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BD (SUZHOU) INTIMA-II Y 20GAX1.16IN PRN/EC SLM CATHETER Back to Search Results
Catalog Number 383012
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 01/20/2021
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 intima-ii y 20gax1. 16in prn/ec slm had foreign matter. The following information was provided by the initial reporter: when the closed vein indwelling needle was used in the puncture room of the first ct room , the new package of 20g indwelling needle no. 383012 was opened, and multiple stains and rust were found on the needle hub and rubber plug.
 
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Brand NameINTIMA-II Y 20GAX1.16IN PRN/EC SLM
Type of DeviceCATHETER
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 Key11335892
MDR Text Key238663344
Report Number3006948883-2021-00236
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,Followup
Report Date 03/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383012
Device Lot Number0267245
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2021
Was Device Evaluated by Manufacturer? Yes
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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