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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOGUARD BL 22GA X 1.0IN INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOGUARD BL 22GA X 1.0IN INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381423
Device Problem Retraction Problem (1536)
Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Event Date 11/04/2020
Event Type  Injury  
Manufacturer Narrative
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 that insyte autoguard bl 22ga x 1. 0in had a needle retraction failure. The following information was provided by the initial reporter: material no: 381423 batch no: 0139118. It was reported needle retraction failure, and needle stick. Verbatim: per customer's response on 02/22/2021. **** was the nurse involved. No medical attention required. But post-exposure source patient labs were drawn on the patient. Spoke to ****. She is okay after this incident. She started an iv and then when she pushed the button to retract the needle, it did not retract. When she was trying to push the button and retract the needle, she bumped the needle into her other hand, left index finger. Patient was aware of the situation. Source labs were drawn. No medical attention needed. Here in the infusion clinic, we did have an insyte that the needle did not retract after use and the nurse stuck herself on it.
 
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Brand NameINSYTE AUTOGUARD BL 22GA X 1.0IN
Type of DeviceINTRAVASCULAR 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11529596
MDR Text Key254023153
Report Number1710034-2021-00211
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903814237
UDI-Public00382903814237
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number381423
Device Lot Number0139118
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/19/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/19/2021 Patient Sequence Number: 1
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