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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 INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383078
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/20/2021
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.
 
Event Description
It was reported when using the bd intima-ii¿ closed iv catheter system the catheter broke/separated from the hub. The following information was provided by the initial reporter. The customer stated: "when the pediatric nurse visited the ward, he found the retention needle had a broken tube and needed to do a ct to check of the broken tube position. On 2021-10-26 received update from sales representative, event description updated as follows: the hospital confirmed that a broken tube was found in the digestive tract and described the child as having been excreted out of the body.
 
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Brand NameBD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
Type of DeviceINTRAVASCULAR 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 Key12839071
MDR Text Key285228063
Report Number3014704491-2021-00280
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,Followup
Report Date 11/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383078
Device Lot Number1111431
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/22/2021
Was Device Evaluated by Manufacturer? Yes
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

Patient Treatment Data
Date Received: 11/18/2021 Patient Sequence Number: 1
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