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

Model Number	392654
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the blood control on the bd insyte¿ autoguard¿ bc pro shielded iv catheter with blood control technology would not work during use.The following information was provided by the initial reporter: "cannot break blood control.".
Event or Problem Description
It was reported that the blood control on the bd insyte¿ autoguard¿ bc pro shielded iv catheter w/ blood control technology wouldn't work during use.The following information was provided by the initial reporter: "can't break blood control".
Additional Manufacturer Narrative
The following fields were updated due to additional information: device available for eval yes, returned to manufacturer on: 17-jan-2023 investigation summary bd received twelve 10 gauge insyte autoguard blood control pro winged units from lot 1068446 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 units and observed no physical damage or deformities that could have caused or contributed to the reported defect.Next, the units were flushed to check for adequate fluid flow and proper function of the actuators.Each unit was flushed successfully with no issues or delays observed.Finally, a luer-lok syringe was used to flush the devices in case there might be an issue with the connector and no issues were found.The actuators functioned properly for each unit.Therefore, based off the visual inspection and testing the engineer was unable to verify the reported defect.Since no defects were found during inspection a definitive root cause could not be determined.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER W/ BLOOD CONTROL TECHNOLOGY
• Common Device Name: 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: 16219422
• Report Number: 1710034-2023-00021
• Device Sequence Number: 7388816
• Product Code: FOZ
• UDI-Device Identifier: 00382903926541
• UDI-Public: 00382903926541
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2023

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
• Operator of Device: Other
• Device Expiration Date: 02/29/2024
• Device Model Number: 392654
• Device Catalogue Number: 392654
• Device Lot Number: 1068446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2023
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 03/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown