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

Model Number 382533

Device Problems Leak/Splash (1354); Improper Flow or Infusion (2954)

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

Event Date 12/21/2022

Event Type  malfunction  

Event Description

It was reported while using bd insyte¿ autoguard¿ bc shielded iv catheter with blood control the blood control did not work and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: these are blood control catheters and the customer is reporting that they are malfunctioning and not controlling the blood flow as they should be.This happens after the clinician uses on the patient, not during use." the valves are not working causing the blood to flow out and get on to the patient.

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.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 06-jan-2023.H6: investigation summary: bd received an unsealed 20 gauge insyte autoguard blood control unit from lot 2242840 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit and observed no visible damage to the device.Next, a water/air leak test was performed using a model vein.During testing, fluid appeared to be leaking from the vent plug of the device.An unused unit was then tested for comparison and there was a noticeable difference between the sample unit and the unused unit.Upon further inspection, the returned unit appeared to have more space on the edges around the plug allowing for the discrepancy observed.Therefore, based off visual inspection and testing the engineer was able to verify the reported defect.It was determined that this was a manufacturing defect that occurred due to improper machine set-up.

Event Description

It was reported while using bd insyte¿ autoguard¿ bc shielded iv catheter with blood control the blood control did not work and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: these are blood control catheters and the customer is reporting that they are malfunctioning and not controlling the blood flow as they should be.This happens after the clinician uses on the patient, not during use" the valves are not working causing the blood to flow out and get on to the patient.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL
• 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: 16141829
• MDR Text Key: 308148458
• Report Number: 1710034-2022-00912
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825332
• UDI-Public: (01)00382903825332
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

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: Other
• Device Model Number: 382533
• Device Catalogue Number: 382533
• Device Lot Number: 2242840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/11/2023
• Supplement Dates Manufacturer Received: 02/08/2023
• Supplement Dates FDA Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• 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