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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE-N AUTOGUARD CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE-N AUTOGUARD CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Lot Number 1158844
Device Problems Break (1069); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Staff went through 5 bd insyte-n autoguard catheters before getting to one that worked; 2 had the catheter stuck in the cap, 2 the needle popped right away, and one had a bent catheter. All had the same lot number and were the same 24g short. This variance never reached the patient. Fda safety report id # (b)(4).
 
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Brand NameBD INSYTE-N AUTOGUARD
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
franklin lakes NJ 07417 1880
MDR Report Key12711268
MDR Text Key279279664
Report NumberMW5104985
Device Sequence Number1
Product Code FOZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 10/25/2021
5 Devices were Involved in the Event: 1   2   3   4   5  
0 Patients were Involved in the Event:
Date FDA Received10/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number1158844
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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