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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD ARTERIAL CANNULA WITH FLOSWITCH 20G/45MM
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BD BD ARTERIAL CANNULA WITH FLOSWITCH 20G/45MM Back to Search Results
Catalog Number 682245
Device Problem Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/12/2014
Event Type  Injury  
Event Description
It was reported that while a patient was in the recovery department after having had a surgery, a bd arterial cannula with floswitch was removed from the patient.Per the report, the cannula had detached from the device and remained inside the patient.The patient received an ultrasound, which located the cannula and the cannula was subsequently removed surgically.
 
Manufacturer Narrative
It is unknown if a sample will be returned for evaluation.If a sample is received, a supplemental report will be filed upon completion of the investigation.
 
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Brand Name
BD ARTERIAL CANNULA WITH FLOSWITCH 20G/45MM
Type of Device
ARTERIAL CANNULA
Manufacturer (Section D)
BD
one becton drive
franklin lakes NJ 07417
Manufacturer Contact
aaron larson
one becton drive
franklin lakes, NJ 07417
8015652406
MDR Report Key4377184
MDR Text Key16989956
Report Number2243072-2014-00303
Device Sequence Number1
Product Code DWF
Combination Product (y/n)N
Reporter Country CodeUK
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 12/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number682245
Initial Date Manufacturer Received 12/15/2014
Initial Date FDA Received12/18/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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