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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 No Code Available (3191)
Event Date 09/11/2019
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.
 
Event Description
It has been reported that one intima-ii y 24gax0. 75in prn/ec slm has been found with loose tubing clamp during use. The following has been provided by the initial reporter: on 9:00 am (b)(6) 2019, when the patient was sealing the tube in the infusion room, the nurse found that the retaining needle infusion clamp could not close tightly, which led to the patient's infusion reflux.
 
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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 Key9192696
MDR Text Key179488378
Report Number3006948883-2019-00865
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 10/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/20/2021
Device Catalogue Number383033
Device Lot Number8141415
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 Received09/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/21/2018
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: 10/15/2019 Patient Sequence Number: 1
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