• 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. 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC INTERVASCULAR 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. 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC INTERVASCULAR CATHETER Back to Search Results
Catalog Number 381033
Device Problems Defective Device (2588); Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/26/2019
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: visual/microscopic evaluation: white particulate was present at the tip of the catheter tubing. The particulate was identified to be porous plug shavings; the porous plug shavings exceeded 0. 2 square millimeters measured per tappi dirt estimation chart. Based on the evaluation of the submitted photos; two of the photos displayed white particulate on the catheter tubing. Which is the same finding as that of the evaluation of the returned unit. Investigation conclusion: a complaint history check was performed, and this is the 1st related complaint reported with the defect/condition of catheter tip integrity with lot #8087872 regarding item #381033. No negative trends identified. A formal corrective action will not be initiated at this time. Customer complaint trends are evaluated on a monthly basis. If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time. Product quality is evaluated during the manufacturing process with prescribed variable and attributes inspections. These inspections are performed by operators and/or process control technicians to ensure any gross process changes are identified. If defects are observed, disposition of the product, root cause and corrective action are applied according to the quality control plan.
 
Event Description
It was reported that the 20g x 1. 00in (1. 1 x 25 mm) insyte autoguard bc experienced foreign matter contamination. The following information was provided by the initial reporter: "the catheter tip was defect. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC
Type of DeviceINTERVASCULAR 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 Key8509566
MDR Text Key145525725
Report Number1710034-2019-00406
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 04/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2021
Device Catalogue Number381033
Device Lot Number8087872
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2018
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: 04/12/2019 Patient Sequence Number: 1
-
-