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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II Y 22GAX1.00IN PRN/EC SLM CATHETER

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BD (SUZHOU) INTIMA-II Y 22GAX1.00IN PRN/EC SLM CATHETER Back to Search Results
Catalog Number 383019
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Pain (1994)
Event Date 03/15/2021
Event Type  Injury  
Manufacturer Narrative
Initial reporter phone#: (b)(6). 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 was reported that there was an infection on the puncture site while using intima-ii y 22gax1. 00in prn/ec slm. The following information was provided by the initial reporter: three hours after the nurse pulled out the needle for him, the patient reported pain in his right hand. Observation revealed obvious redness and swelling at the puncture site of the indwelling needle, and high temperature of the surrounding local skin. The next day pus appeared at the puncture site, the patient was immediately given anti-infective treatment and the infection was reported. 2021-4-19 received an update from the sales representative, and the description of the incident was updated as follows: after communicating with the user department, after using the bd indwelling needle to withdraw the needle, it was found that the puncture site of the indwelling needle was redness and swollen, the surrounding local skin temperature was high, and pus appeared at the puncture point the next day. It may be related to the patient's own blood vessel conditions and the unstandardized flushing tube for mannitol infusion. The indwelling needle itself does not have problems such as blunt needles, difficulty in puncture, needle burrs, sterility problems, foreign bodies, etc.
 
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Brand NameINTIMA-II Y 22GAX1.00IN PRN/EC SLM
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11805761
MDR Text Key249974291
Report Number3006948883-2021-00536
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 05/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number383019
Device Lot Number9169531
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 Received05/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/18/2019
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: 05/11/2021 Patient Sequence Number: 1
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