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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ INTIMA-II CATHETER

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BECTON DICKINSON UNSPECIFIED BD¿ INTIMA-II CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Phlebitis (2004)
Event Date 07/06/2021
Event Type  Injury  
Manufacturer Narrative
Unknown manufacturer: (b)(4). 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 unspecified bd¿ intima-ii catheter was used and the patient had an allergic reaction. The following information was provided by the initial reporter: after the patient was admitted to the hospital on (b)(6) 2021 due to gastroenteritis, the vein access was opened, and after two hours of intravenous drip, the family found that the puncture site of the patient's arm was red and swollen, and the patient complained of pain at the puncture site. Then i called the nurse, who found that the phlebitis was caused above the puncture site of the patient, stopped the fluid immediately, pulled out the indwelling needle and informed the doctor. Apply magnesium sulfate solution for wet compress for 15-20 minutes each time, 3-4 times a day, apply erythrycin ointment after wet compress, and recover at 9:00 am on (b)(6) 2021.
 
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Brand NameUNSPECIFIED BD¿ INTIMA-II CATHETER
Type of DeviceCATHETER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key12339967
MDR Text Key267230948
Report Number2243072-2021-02104
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 08/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/18/2021 Patient Sequence Number: 1
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