MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOGUARD; PERIPHERAL IV CATHETERS

Catalog Number	381512
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G.4.K201075; k251654.H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.E1.Address information was not provided; therefore, (b)(6) was used as the state.
Event or Problem Description
It was reported that the needle did not retract.I had an issue with the automatic push-button needle retraction safety mechanism at work today.The needle did not retract into the protective chamber when the safety button was depressed.Additional information 3/13/2026: the issue happened when i was visiting the patient's home and using the product to start an iv.Supplies shipped by accredo.No injury to me, but i did end up having to restart the iv on the patient (extra needle stick) date of event: 11-03-2026 the needle did not retract at all when the white button was pressed.The needle not move at all after pressing the button.
Additional Manufacturer Narrative
The complaint that the needle did not retract was confirmed from the video that was provided for investigation.The video showed a needle from an insyte autoguard device.The video demonstrated what appeared to be the button being pressed multiple times to activate the safety mechanism.The needle did not retract when the button was pressed, which was consistent with adhesive bonding the needle hub to the safety mechanism.No other similar complaints were reported from the implicated lot.The manufacturing personnel were notified of this complaint.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Complaints received about this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the data collected for identification of emerging trends.
Event or Problem Description
No new information.

• Brand Name: INSYTE AUTOGUARD
• Common Device Name: PERIPHERAL IV CATHETERS
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24640657
• Report Number: 1710034-2026-00295
• Device Sequence Number: 10168835
• Product Code: FOZ
• UDI-Device Identifier: 00382903815128
• UDI-Public: (01)00382903815128(11)250924(17)280831(10)5267948
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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 Catalogue Number: 381512
• Device Lot Number: 5267948
• 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: 03/11/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown