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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-N WINGED, 24G X 0.56"; INTRAVASCUALR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD-N WINGED, 24G X 0.56"; INTRAVASCUALR CATHETER Back to Search Results
Model Number 381511
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/27/2022
Event Type  malfunction  
Event Description
It was reported while using bd insyte autoguard-n winged, 24g x 0.56" the catheter backs out of the vein.There was no report of patient impact.The following information was provided by the initial reporter: sometimes you can see under the skin where the needed has split the catheter and its making what looks like a bubble.If you pull the needle out of the catheter to check for blood flow it is difficult if not impossible to feed it back through the catheter.Other times when you pull back the needle to check for blood flow it catches on the catheter and the whole thing pulls out.
 
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
Investigation summary: our quality engineer inspected the photographs submitted for evaluation.Bd received two photographs which displayed four different 24g insyte-n autoguard units.One photo showed one 24g insyte-n autoguard winged device.The other photo showed three 24g insyte-n autoguard winged devices.These photographs were submitted for each reported issue.The photos confirmed the issue of the needle protruding through the side of the catheter.A catheter spear through could potentially cause the needle to catch on the catheter tubing when pulling back the needle, causing both components to back out of the vein.As the provided pictures do not provide any other evidence that could indicate a different root cause, the reported defect of the catheter backing out of the vein remains a concomitant failure of the needle piercing the catheter.Due to the evidence of use, the needle likely punctured the catheter during the insertion process.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-n winged, 24g x 0.56" the catheter backs out of the vein.There was no report of patient impact.The following information was provided by the initial reporter: sometimes you can see under the skin where the needed has split the catheter and its making what looks like a bubble.If you pull the needle out of the catheter to check for blood flow it is difficult if not impossible to feed it back through the catheter.Other times when you pull back the needle to check for blood flow it catches on the catheter and the whole thing pulls out.
 
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Brand Name
BD INSYTE AUTOGUARD-N WINGED, 24G X 0.56"
Type of Device
INTRAVASCUALR 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 Key15998596
MDR Text Key308254623
Report Number1710034-2022-00821
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903815112
UDI-Public(01)30382903815112
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K952861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number381511
Device Catalogue Number381511
Device Lot Number2241103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/29/2022
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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