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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BLOOD CONTROL; INTERVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BLOOD CONTROL; INTERVASCULAR CATHETER Back to Search Results
Catalog Number 381012
Device Problem Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/29/2022
Event Type  malfunction  
Event Description
It was reported while using bd insyte¿ autoguard¿ blood control the needle wouldn't fully retract.This occurred 4 times.There was no report of patient impact.The following information was provided by the initial reporter: needle doesn't push back.
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.
 
Event Description
It was reported while using bd insyte¿ autoguard¿ blood control the needle wouldn't fully retract.This occurred 4 times.There was no report of patient impact.The following information was provided by the initial reporter: needle doesn't push back.
 
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Brand Name
BD INSYTE¿ AUTOGUARD¿ BLOOD CONTROL
Type of Device
INTERVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15670497
MDR Text Key302495066
Report Number1710034-2022-00625
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K201075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number381012
Device Lot Number2174500
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/22/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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