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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 Hemorrhage/Bleeding (1888)
Event Date 10/18/2021
Event Type  malfunction  
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¿ arterial cannula there was a defective flow switch and leakage. This event occurred 4 times. The following information was provided by the initial reporter. The customer stated: "several cases (4) of cannulas that the red button does not close effectively, and as a result the arterial blood is flowing through the cannula and outside the artery. ".
 
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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 Key12838463
MDR Text Key285544605
Report Number8041187-2021-00987
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeGR
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 12/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number682245
Device Lot Number1053403
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/22/2021
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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