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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER

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BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383033
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/22/2021
Event Type  malfunction  
Event Description
It was reported that the bd intima-ii¿ closed iv catheter system experienced a mix of product types in a pack. The following information was provided by the initial reporter: medical care in obstetrics for pregnant women found after opening the package that the product was inconsistent with the packaging.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
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Brand NameBD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
Type of DeviceINTERVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
no.1 liangpu street
suzhou industrial park
suzhou 21512 6
CH 215126
Manufacturer (Section G)
BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
no.1 liangpu street
suzhou industrial park
suzhou 21512 6
CH 215126
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12845092
MDR Text Key286134312
Report Number3014704491-2021-00281
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 Other Health Care Professional
Type of Report Initial
Report Date 11/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383033
Device Lot Number1111402
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/21/2021
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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