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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ARTERIAL CANNULA ARTERIAL CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD ARTERIAL CANNULA ARTERIAL CATHETER Back to Search Results
Catalog Number 682245
Device Problem Complete Blockage (1094)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/16/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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 kinking occurred during use with a bd arterial cannula. The following information was provided by the initial reporter, "we have observed an increasing number of problems with arterial pressure monitoring after cannula exchange. We get worse quality on arterial curve readings. Have to exchange cannula several times because ti does not function. Looks as if the catheter that goes into the artery is kinking at the point between the "house" and the "gliding lock". Looks as if the connection in that area is too weak, we can see the catheter bending and hence the bad quality on the curves. ".
 
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Brand NameBD ARTERIAL CANNULA
Type of DeviceARTERIAL CATHETER
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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8711858
MDR Text Key149688095
Report Number8041187-2019-00467
Device Sequence Number1
Product Code DQR
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number682245
Device Lot Number8230345
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/18/2018
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: 06/19/2019 Patient Sequence Number: 1
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