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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA II IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER

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BD (SUZHOU) BD INTIMA II IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383019
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Inflammation (1932)
Event Date 09/16/2020
Event Type  Injury  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Fda device problem code: 2993, fda patient problem code: 1932.
 
Event Description
It was reported that the patient developed swelling at the bd intima ii¿ iv catheter prn adapter puncture site during the infusion, which was diagnosed as phlebitis. The needle was removed, local symptomatic treatment was performed, and the patient's symptoms were gone by the following day. The following information was provided by the initial reporter, translated from chinese to english: "the patient was admitted for treatment due to "femoral neck fracture". On the fourth day of admission, the nurse noticed redness and swelling at the puncture site during infusion at 9 am. The patient reported local pain, which was diagnosed as phlebitis by the attending physician, the disposable indwelling needle immediately removed with local symptomatic treatment, one day later the symptoms was disappeared".
 
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Brand NameBD INTIMA II IV CATHETER PRN ADAPTER
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 Key10715071
MDR Text Key212446014
Report Number3006948883-2020-00593
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 11/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2021
Device Catalogue Number383019
Device Lot Number8262024
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 Received11/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/19/2018
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: 10/21/2020 Patient Sequence Number: 1
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