MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC; INTERVASCULAR CATHETER

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.".

• Brand Name: 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC
• Type of Device: INTERVASCULAR 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 Key: 8509566
• MDR Text Key: 145525725
• Report Number: 1710034-2019-00406
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• 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 Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 381033
• Device Lot Number: 8087872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other