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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/20/2021
Event Type  Injury  
Manufacturer Narrative
H. 3. 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 the bd intima-ii¿ closed iv catheter system was involved with a serious injury. While no malfunction was observed, the device was involved with a patient receiving an x-ray scan. The scan results determined no additional medical intervention was needed. The following information was provided by the initial reporter: the family was going to prepare to give child a bath, they found that the child was biting needle and swallowed some part, see the needle indwelling needle is found to heparin cap yellow colloid is missing, the heparin cap body without loss, children with oral face no cyanosis, doctors, nurses and report immediately to the stomach head low foot high back on gag reflex processing, the processed with no vomiting. No cyanosis of lips, smooth breathing, x-ray detection results were normal, the family members were instructed to feed more milk and water to promote excretion, the family members had no objection.
 
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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 Key12606164
MDR Text Key281279522
Report Number3014704491-2021-00192
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 10/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number383033
Device Lot Number0202466
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/20/2020
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: 10/11/2021 Patient Sequence Number: 1
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