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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. INTIMA-II Y18GAX1.16IN PRN/EC SLM CATHETER

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BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. INTIMA-II Y18GAX1.16IN PRN/EC SLM CATHETER Back to Search Results
Catalog Number 383005
Device Problem Leak/Splash (1354)
Patient Problems Dyspnea (1816); Chest Tightness/Pressure (2463)
Event Date 02/23/2020
Event Type  Injury  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that an intima-ii y18gax1. 16in prn/ec slm leaked. The following information was provided by the initial reporter: "the male patient had paroxysmal chest tightness and shortness of breath for half a month. At 14:03 on (b)(6) 2020, when coronary ct was performed, the end cap of the positive pressure indwelling needle was loosen, and the iohexol contrast agent was leaked out, it was caused the patient to undergo repeated examinations and received excess radiation and the needle was immediately changed the contrast agent and re-punctured again. ".
 
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Brand NameINTIMA-II Y18GAX1.16IN PRN/EC SLM
Type of DeviceCATHETER
Manufacturer (Section D)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
Manufacturer (Section G)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key10060918
MDR Text Key191139535
Report Number3006948883-2020-00187
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 06/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383005
Device Lot Number9077588
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 Received04/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/18/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/15/2020 Patient Sequence Number: 1
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