• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOG BC GLOBAL PNK 20GA X 1.16IN INTRAVASCULAR CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOG BC GLOBAL PNK 20GA X 1.16IN INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381034
Device Problem Delivered as Unsterile Product (1421)
Patient Problem Needle Stick/Puncture (2462)
Event Date 07/07/2019
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that before use of the insyte autog bc global pnk 20ga x 1. 16in when the user was opening the package the needle pricked the user. There was eight packages that had the needles uncovered. Only one needle poke took place. The following information was provided by the initial reporter: when the user's product wrapping paper open. Needle prick accident occurred.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINSYTE AUTOG BC GLOBAL PNK 20GA X 1.16IN
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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8839207
MDR Text Key153856810
Report Number1710034-2019-00807
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeKS
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 09/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2021
Device Catalogue Number381034
Device Lot Number8318508
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2018
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: 07/29/2019 Patient Sequence Number: 1
-
-