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

Catalog Number	381444
Medical Device Problem Codes	Leak/Splash (1354); Retraction Problem (1536); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 bd insyte¿ autoguard¿ shielded iv catheter vent plug was missing, causing blood to leak out when pressing the button to retract the needle.The following information was provided by the initial reporter: "from the 2 nurses that were in the room, one using the iv and the other that was charting that looked at it afterwards.There is a little film type thing at the end of the iv ¿handle¿ where the needle sucks into to when the safety button is pressed.On that particular one, there was no film present.The blood was then shot backwards through the hole by the spring loading pulling the needle into it and onto the staff member holding it.Then the blood still inside the handle dripped out when inverted, due to the missing film piece, on to the pts bed and floor as well.What was the patient or staff impact?: staff uniform was soiled with blood.What was the patient or staff outcome?: scrubs laundered by hospital, will replace if unable to remove blood.Was there any exposure to blood or bodily fluid?: yes.Would you say this is a retraction issue?: yes.".
Additional Manufacturer Narrative
Investigation summary a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 2290797, and no quality issues were found during production.Our quality engineer reviewed the provided photo but could not identify any issues with the safety retraction system.From the provided photo the safety mechanism had not yet been activated for retraction.Therefore, based off the provided photo the engineer could not verify the reported defect.Since no defects were found a definitive root cause could not be determined.For a more thorough investigation into this issue a physical sample will need to be returned for inspection.The manufacturing facility has been notified of this incident and the findings.
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter vent plug was missing, causing blood to leak out when pressing the button to retract the needle.The following information was provided by the initial reporter: "from the 2 nurses that were in the room, one using the iv and the other that was charting that looked at it afterwards.There is a little film type thing at the end of the iv ¿handle¿ where the needle sucks into to when the safety button is pressed.On that particular one, there was no film present.The blood was then shot backwards through the hole by the spring loading pulling the needle into it and onto the staff member holding it.Then the blood still inside the handle dripped out when inverted, due to the missing film piece, on to the pts bed and floor as well.What was the patient or staff impact? staff uniform was soiled with blood.What was the patient or staff outcome? scrubs laundered by hospital, will replace if unable to remove blood.Was there any exposure to blood or bodily fluid? yes.Would you say this is a retraction issue? yes".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• 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 ; 8448235433
• MDR Report Key: 16513355
• Report Number: 1710034-2023-00216
• Device Sequence Number: 12354069
• Product Code: FOZ
• UDI-Device Identifier: 00382903814442
• UDI-Public: 00382903814442
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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: Health Professional
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: 381444
• Device Lot Number: 2290797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2022
• 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