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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¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY; INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY; INTRAVASCULAR CATHETER Back to Search Results
Model Number 382523
Device Problem Retraction Problem (1536)
Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Event Date 10/28/2022
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported while using bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology the needle would not retract and a dirty needle stick occurred.The following information was provided by the initial reporter: nurse got stuck with a needle due to a malfunctioning iv device, the needle did not retract she went to occ health, they told her what to do with the patient, and sers was completed.
 
Manufacturer Narrative
H6: investigation summary our quality engineer inspected the sample submitted for evaluation.Bd received one needle in the barrel of an insyte autoguard unit.A gross visual inspection shows a unit that has been used and the needle retracted in the barrel.The barrel has some stress marks and has a slight bent near the rear end.The safety button has a crack, and it is fully engaged.In attempt to reproduce the issue of retraction failure, the needle was reengaged by pushing it out.The safety button was pushed, and the needle retracted but stopped at the bent on the barrel.The reported issue was confirmed.Although the reported issue was confirmed, it could not be determined if the damage resulted from the manufacturing of the device or from the user environment.Without the complete device, a full investigation could not be performed.This type of defect may occur during manufacturing due to a damaged barrel from machine misalignment.However, since the device has been handled, therefore this defect could have occurred in the used environment due to improper handling or storage condition.A device history review (dhr) cannot be performed as no lot number was provided by the complainant.Without the other part of the device to identify additional damages, the root cause cannot be determined with certainty.H3 other text : see h10.
 
Event Description
It was reported while using bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology the needle would not retract and a dirty needle stick occurred.The following information was provided by the initial reporter: nurse got stuck with a needle due to a malfunctioning iv device, the needle did not retract she went to (b)(6) health, they told her what to do with the patient, and sers was completed.
 
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Brand Name
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY
Type of Device
INTRAVASCULAR 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 Key15859256
MDR Text Key307775639
Report Number1710034-2022-00728
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903825234
UDI-Public(01)30382903825234
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110443
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 01/03/2023
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? Yes
Device Operator Health Professional
Device Model Number382523
Device Catalogue Number382523
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/31/2022
Initial Date FDA Received11/23/2022
Supplement Dates Manufacturer Received01/03/2023
Supplement Dates FDA Received01/17/2023
Was Device Evaluated by Manufacturer? Yes
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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