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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOG BC PNK 20GA X 1.0IN INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOG BC PNK 20GA X 1.0IN INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 382533
Device Problem Retraction Problem (1536)
Patient Problem Needle Stick/Puncture (2462)
Event Date 02/16/2021
Event Type  malfunction  
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 autog bc pnk 20ga x 1. 0in was partially retracted and the employee was stuck with the needle. The following information was provided by the initial reporter: material no:382533, batch no: 0307311. It was reported that the employee was stuck with the needle on two separate occasions. Verbatim: our customer has reported 1st incident was (b)(6) and employee was stuck with the needle. Employee did take picture of iv catheter but then disposed of the cath. Management pulled from the same lot and tried to recreate the issue with no success. 2nd incident (b)(6) and the exact same thing happened again, this time no injury involved.
 
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Brand NameINSYTE AUTOG BC PNK 20GA 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 Key11586669
MDR Text Key242897192
Report Number1710034-2021-00253
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903825332
UDI-Public00382903825332
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 foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number382533
Device Lot Number0307311
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 Received04/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/03/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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