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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ARTERIAL CANNULA 20G/45MM CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD ARTERIAL CANNULA 20G/45MM CATHETER Back to Search Results
Catalog Number 682245
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 09/25/2021
Event Type  Injury  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd arterial cannula 20g/45mm had blood coming out and the catheter broke. The following information was provided by the initial reporter:. While removing the arterial cannula plaster, from the site blood was gushing and they had to apply pressure. After the bleeding stopped, arterial cannula removed, it was noticed that there was only the cannula hub connected with a 0. 3 mm and remaining part was missing / incomplete. The dressing also was checked. The remaining part found only thru ultrasound.
 
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Brand NameBD ARTERIAL CANNULA 20G/45MM
Type of DeviceCATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer (Section G)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12776492
MDR Text Key280513653
Report Number8041187-2021-00958
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeTC
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 11/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number682245
Device Lot Number0022357
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/22/2020
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: 11/09/2021 Patient Sequence Number: 1
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