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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 SHIELDED IV CATHETER; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE-N AUTOGUARD SHIELDED IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381411
Device Problem Delivered as Unsterile Product (1421)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter facility name: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that the bd insyte-n¿ autoguard¿ shielded iv catheter experienced the needle piercing through the needle shield/cap/cover.The following information was provided by the initial reporter: material no: 381411, batch no: 9207656.Product: bd insyte-n autoguard shielded iv catheter.Number of defective product(s): 1.The needle in this iv catheter pierced the cannula shield and was then unable to be used.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2/16/2021.H.6.Investigation: our quality engineer inspected the sample submitted for evaluation.Bd received one used device with opened packaging and a 10 ml syringe.Visual inspection of the sample revealed that the needle had speared through the tubing wall, confirming the defect of needle through catheter.This type of defect can occur during the manufacturing process or in the clinical setting.The presences of bodily fluids throughout the catheter and needle indicate that the device was correctly assembled at the time of use.Therefore, the defect most likely originated during use.A device history record review showed no non-conformances associated with this issue during the production of this batch.
 
Event Description
It was reported that the bd insyte-n¿ autoguard¿ shielded iv catheter experienced the needle piercing through the needle shield/cap/cover.The following information was provided by the initial reporter: material no: 381411, batch no: 9207656.Product: bd insyte-n autoguard shielded iv catheter.Number of defective product(s): 1.The needle in this iv catheter pierced the cannula shield and was then unable to be used.
 
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Brand Name
BD INSYTE-N AUTOGUARD SHIELDED IV CATHETER
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key11366084
MDR Text Key233970908
Report Number1710034-2021-00130
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K201075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2022
Device Catalogue Number381411
Device Lot Number9207656
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2021
Date Manufacturer Received03/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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