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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER

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BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383406
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Infarction, Cerebral (1771); Dementia (1808); Erythema (1840); Fever (1858); High Blood Pressure/ Hypertension (1908); Swelling (2091); Weakness (2145); Reaction (2414)
Event Date 03/19/2020
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.
 
Event Description
It was reported that bd intima-ii¿ closed iv catheter system caused an allergic reaction in a patient. The following information was provided by the initial reporter: "on (b)(6) 2020, the patient came to the department of neurology of our hospital for inpatient treatment due to "weakness of the left limb, unclear speech for more than 1 year, and aggravation for more than 10 days". After checking , doctor diagnosed with these questions, 1 cerebral infarction and vascular dementia; 2. Type 2 diabetes mellitus; 3. Hypertension level 3 high risk group; 4. Premature coronary heart disease; 5. Degeneration of the right knee joint; 6. Lumbar disc herniation. On (b)(6), the nurse used closed vein indwelling needle to treat the patient with infusion, and at 21 o 'clock on (b)(6), the patient developed fever, and the body temperature was 38. 3¿. The nurse found that the venipuncturing site of the right hand had about 1cm×1cm abscess, which was locally suppurated, and the surrounding skin was red and swollen. The possibility of bacteremia was not excluded. ".
 
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Brand NameBD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
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 Key10022064
MDR Text Key193334004
Report Number3006948883-2020-00161
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K143610
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 05/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/06/2020
Device Catalogue Number383406
Device Lot Number7265024
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 Received04/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/22/2017
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: 05/04/2020 Patient Sequence Number: 1
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