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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD ARTERIAL CANNULA WITH FLOWSWITCH 20G X 45MM
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BD BD ARTERIAL CANNULA WITH FLOWSWITCH 20G X 45MM Back to Search Results
Catalog Number 682245
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem Hemorrhage/Bleeding (1888)
Event Type  Injury  
Event Description
The clinician found oozing on the right radial arterial dressing and decided to change the dressing.While changing the dressing, the clinician found the arterial catheter broken.The clinician attempted to look for the broken catheter but could not find it.An ultrasound was performed which found the catheter retained in the patient's artery.The patient was evaluated by a surgeon and a surgery was done to remove the retained catheter.
 
Manufacturer Narrative
The sample is available for evaluation.Upon receipt of the sample, the completion of the investigation, a supplemental report will be submitted.
 
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Brand Name
BD ARTERIAL CANNULA WITH FLOWSWITCH 20G X 45MM
Type of Device
ARTERIAL CANNULA
Manufacturer (Section D)
BD
one becton drive
franklin lakes NJ 07417 188
Manufacturer Contact
aaron larson, rn, bsn
one becton drive
franklin lakes, NJ 07417
8015652406
MDR Report Key4186060
MDR Text Key19585920
Report Number2243072-2014-00203
Device Sequence Number1
Product Code DWF
Combination Product (y/n)N
Reporter Country CodeTC
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 10/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/31/2018
Device Catalogue Number682245
Device Lot Number303349
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer09/21/2014
Initial Date Manufacturer Received 09/21/2014
Initial Date FDA Received10/02/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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