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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC CATHETER

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BD (SUZHOU) INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC CATHETER Back to Search Results
Catalog Number 383062
Device Problem Free or Unrestricted Flow (2945)
Patient Problems Dyspnea (1816); Chest Tightness/Pressure (2463)
Event Date 10/30/2020
Event Type  Injury  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that intima-ii y 20gax1. 16in prn ec slm npvc had air in the line. The following information was provided by the initial reporter: during the infusion, the patient complained of chest tightness, dyspnea and slight cough. After investigation of the cause of the drug, it was found that the intravenous indwelling needle was not qualified for sealing, leading to a small amount of air entering, which caused unnecessary injury to the patient.
 
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Brand NameINTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC
Type of DeviceCATHETER
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
8015296192
MDR Report Key11008753
MDR Text Key221524758
Report Number3006948883-2020-00949
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
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 01/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383062
Device Lot Number9262029
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 Received01/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/19/2019
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: 12/15/2020 Patient Sequence Number: 1
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