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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD INSYTE AUTOGUARD INTRAVASCULAR CATHETER
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BD BD INSYTE AUTOGUARD INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381833
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Tissue Damage (2104)
Event Type  Injury  
Event Description
It was reported that while using a bd insyte autoguard intravascular catheter, the catheter broke off form the catheter hub and remained inside the patient.The patient was participating in a (b)(4) study.The attending physician notified vascular surgery and the surgeon determined an urgent venotomy was required to remove the foreign body.The patient had surgery to remove the broken catheter.
 
Manufacturer Narrative
A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
 
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Brand Name
BD INSYTE AUTOGUARD INTRAVASCULAR CATHETER
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BD
1 becton dr.
franklin lakes NJ 07417 188
Manufacturer (Section G)
BD
9450 s. state st.
sandy UT 84070
Manufacturer Contact
aaron larson
1 becton dr.
franklin lakes, NJ 07417-1880
8015652406
MDR Report Key4258850
MDR Text Key5104438
Report Number2243072-2014-00278
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/31/2017
Device Catalogue Number381833
Device Lot Number4143917
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/07/2014
Date Manufacturer Received11/04/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/01/2014
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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