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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTERVASCULAR CATHETER

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BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383033
Device Problem Leak/Splash (1354)
Patient Problem Infarction, Cerebral (1771)
Event Date 10/09/2019
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.
 
Event Description
It was reported that the intima-ii y 24gax0. 75in prn/ec sl experienced leakage during use. The following information was provided by the initial reporter: due to cerebral infarction, the patient was treated with intima-ii infusion on (b)(6) 2019. On (b)(6), fluid leakage was found in the indwelling needle hose during infusion, and the catheter was immediately stopped and replaced with a new indwelling needle for smooth infusion.
 
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Brand NameINTIMA-II Y 24GAX0.75IN PRN/EC SLM
Type of DeviceINTERVASCULAR CATHETER
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 Key9355596
MDR Text Key179454340
Report Number3006948883-2019-00961
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
N/A
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 12/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/07/2021
Device Catalogue Number383033
Device Lot Number8017215
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/17/2018
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: 11/21/2019 Patient Sequence Number: 1
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