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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II Y 24GAX0.56IN PRN/PRN SLM NPVC INTRAVASCULAR CATHETER

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BD (SUZHOU) INTIMA-II Y 24GAX0.56IN PRN/PRN SLM NPVC INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383087
Device Problem Leak/Splash (1354)
Patient Problem Unspecified Infection (1930)
Event Date 12/02/2019
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 heparin cap fell off the intima-ii y 24gax0. 56in prn/prn slm npvc during use after the infusion of anti-infection medication. The catheter was used on a child patient admitted to the hospital for pneumonia. The following information was provided by the initial reporter, translated from (b)(6) to english: "on (b)(6) 2019, the child was admitted to hospital for the diagnosis of pneumonia, and the patient was treated with intravenous infusion for anti-infection. After the infusion of liquid to seal the tube, the heparin cap fell off by itself, and the new needle was re-punctured due to contamination".
 
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Brand NameINTIMA-II Y 24GAX0.56IN PRN/PRN SLM NPVC
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer (Section G)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9535780
MDR Text Key181439950
Report Number3006948883-2019-01146
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 01/24/2020
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 Date09/14/2020
Device Catalogue Number383087
Device Lot Number7234118
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 Received12/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/22/2017
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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