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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 CATHETER, INTRAVASCULAR, THERAPEUTIC

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BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Catalog Number 383033
Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/11/2022
Event Type  malfunction  
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Brand NameBD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15188735
Report Number3014704491-2022-00336
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 Other,Foreign,User Facility
Reporter Occupation
Type of Report Initial
Report Date 08/02/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383033
Device Lot Number2018964
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/11/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/18/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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