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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD INSYTE-N AUTOGUARD IV CATHETER 24G X .56"; INTRAVASCULAR CATHETER
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BD BD INSYTE-N AUTOGUARD IV CATHETER 24G X .56"; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381411
Device Problems Leak/Splash (1354); Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/15/2014
Event Type  Injury  
Event Description
It was reported that a clinician noticed leakage around the patient's insyte-n autoguard dressing.Upon further inspection, the clinician noted that the iv catheter was gone.The pt went to radiology to find the catheter and then underwent surgery to remove the retained iv catheter.
 
Manufacturer Narrative
The sample is available for evaluation.Upon receipt of the sample and completion of the investigation, a supplemental report will be submitted.(b)(4).
 
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Brand Name
BD INSYTE-N AUTOGUARD IV CATHETER 24G X .56"
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BD
one becton dr.
franklin lakes NJ 07417
Manufacturer Contact
aaron larson
one becton dr.
franklin lakes, NJ 07417
8015652406
MDR Report Key4170356
MDR Text Key5158682
Report Number2243072-2014-00199
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/26/2014
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 Catalogue Number381411
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/15/2014
Initial Date FDA Received09/29/2014
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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