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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

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BECTON DICKINSON MEDICAL (SINGAPORE) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM Back to Search Results
Catalog Number 383083
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Reaction (2414)
Event Date 12/05/2019
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 the bd intima-ii¿ closed iv catheter system caused an allergic reaction and required medical intervention. The following information was provided by the initial reporter, translated from (b)(6). Verbatim: ¿the patient was admitted due to fever, and was given q12h intravenous infusion of antibiotics after admission. In order to reduce the frequency and pain of puncture, intravenous indwelling needle was given. The puncture site of the intravenous indwelling needle in the patient was red with secretion and no pain. The indwelling needle was removed to protect the patient with hydrocolloid dressing.
 
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Brand NameBD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
Type of DeviceIV CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
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 Key9682743
MDR Text Key182221035
Report Number3006948883-2020-00053
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 02/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/29/2021
Device Catalogue Number383083
Device Lot Number8079073
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 Received01/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2018
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: 02/07/2020 Patient Sequence Number: 1
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