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

Model Number 381834

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.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 while using bd insyte¿ autoguard¿ iv catheter the silicone was visible on the catheter.There was no report of patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: damage the vein when removing the iv catheter.Potential pain, future complications for patient.It seems that there is an excess of silicone oil and the catheter is sticking to the needle.The problem occurs with nurses who stick directly without unblocking the catheter from the needle before placement.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 03-jan-2023.H6: investigation summary: our quality engineer inspected the representative samples submitted for evaluation.Bd received 50 sealed 20g x 1.16in.Insyte autoguard units from lot nubmer 2165893.The returned units were opened, functionally tested for proper tip adhesion break and finally advanced off the needle hub to identify any potential resistance.A gross visual inspection did not identify and damage or defects to the components.Functional testing found that all units had adequate tip adhesion and no resistance was present when breaking the tip adhesion or advancing the catheter.The returned units provided for evaluation met and performed per the required manufacturing specifications.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failures stated in your report.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported while using bd insyte¿ autoguard¿ iv catheter the silicone was visible on the catheter.There was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: damage the vein when removing the iv catheter.Potential pain, future complications for patient.It seems that there is an excess of silicone oil and the catheter is sticking to the needle.The problem occurs with nurses who stick directly without unblocking the catheter from the needle before placement.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ IV CATHETER
• Type of Device: INTRAVASCULAR 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16097438
• MDR Text Key: 308619018
• Report Number: 1710034-2022-00884
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818341
• UDI-Public: (01)00382903818341
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 381834
• Device Catalogue Number: 381834
• Device Lot Number: 2166913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 01/04/2023
• Supplement Dates Manufacturer Received: 02/01/2023
• Supplement Dates FDA Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2022
• 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