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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Chills (2191)
Event Date 08/28/2019
Event Type  Injury  
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 slm was involved in a serious injury in the form of medical intervention. The patient developed chills while being treated for heart failure, after which dexamethasone was administered. There is no information currently available regarding the final outcome of this incident. The following information was provided by the initial reporter: on (b)(6) 2019, the patient was treated with intima-ii of hermetic intravenous indwelling needle due to heart failure. During the use, the patient developed chills and was immediately stopped. Dexamethasone 5mg was injected intravenously and the patient was relieved after an hour.
 
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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 Key9180812
MDR Text Key162783295
Report Number3006948883-2019-00854
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
UNKNOWN
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 10/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383033
Device Lot Number9077841
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 Received09/26/2019
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: 10/11/2019 Patient Sequence Number: 1
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