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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 383078
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Injury (2348)
Event Date 02/26/2019
Event Type  Injury  
Manufacturer Narrative
Initial reporter phone #: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that after the fourth day, the catheter was removed and was discovered that there was a wound associated with a bd intima-ii¿ closed iv catheter system. The following information was provided by the initial reporter, translated from (b)(6) to english: the patient finished infusion at 13:20 on (b)(6) 26, 2019. After pulling out the intravenous indwelling needle (the fourth day of indwelling catheter), found that there was a 3*1 cm 2 wound associated with medical device at the fixed place of the indwelling needle handle. Local disinfection was immediately given, and removed the shedding skin, and cleaned with brine swabs. After dry care, alginate gel dressing + wound dressing was used for dressing change.
 
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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 Key8965770
MDR Text Key156644778
Report Number3006948883-2019-00731
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 09/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/04/2021
Device Catalogue Number383078
Device Lot Number8079076
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/05/2019 Patient Sequence Number: 1
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