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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. INTIMA-II 24GAX0.56IN PRN SLM NPVC INTERVASCULAR CATHETER

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BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. INTIMA-II 24GAX0.56IN PRN SLM NPVC INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383085
Device Problem Infusion or Flow Problem (2964)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 11/12/2019
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 24gax0. 56in prn slm npvc experienced an incomplete flush during use. The following information was provided by the initial reporter: on (b)(6) 2019, the child was admitted to the hospital due to alveobronchiolitis. Today was the fourth day of admission, and today was the second day of indwelling needle indwelled. The nurse rushed the tube and withdrew blood for the child. Blood clots were found in the indwelling needle tube, and the indwelling needle was immediately replaced, causing the second puncturing of the child without causing other injuries, and then reported to the equipment department.
 
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Brand NameINTIMA-II 24GAX0.56IN PRN SLM NPVC
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 Key9534274
MDR Text Key179943097
Report Number3006948883-2019-01139
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 01/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/22/2021
Device Catalogue Number383085
Device Lot Number7356454
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 Received12/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/22/2017
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: 12/31/2019 Patient Sequence Number: 1
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