MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 382533

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

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 during the use of the bd insyte¿ autoguard¿ bc shielded iv catheter the catheter did not have blood control after removing the needle.

Manufacturer Narrative

Investigation summary: a complaint history check was performed, and this is the 2nd related complaint reported with the defect/condition of leakage beyond the septum (iag bc) with lot #8226673 regarding item #382533.Dhr review was performed on lot number 8226673.The lot number was built / package on afa line 12 from 21aug2018 through 25aug2018.Review of dhr revealed all required challenge samples, set-up and in process testing was performed in accordance with the quality plans.Review disclosed no reject activity findings throughout the build of this lot that would impact the outcome of the quality of the product relevant to the defect stated in the pir.No quality notification were initiated during the build of this lot number.Investigation conclusion: observations and testing could not be performed because units were not received for investigation of this incident.Root cause description: indeterminate ¿ without the actual sample for evaluation and testing there was no physical evidence to confirm or support manufacturing process related issues for the reported defect.Rationale: 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 during the use of the bd insyte¿ autoguard¿ bc shielded iv catheter the catheter did not have blood control after removing the needle.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8203540
• MDR Text Key: 131707280
• Report Number: 1710034-2018-00940
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825333
• UDI-Public: 30382903825333
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 382533
• Device Lot Number: 8226673
• Date Manufacturer Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other