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

Catalog Number	381433
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
The customer advised that the product has retraction issues while in use on patients.
Additional Manufacturer Narrative
The complaint of slow needle retraction was confirmed from the representative 20g insyte autoguard units that were received in sealed packaging from lot #4305273.A functional test showed that the needles fully retracted within the safety shield; however, the retraction time of some units exceeded the 1 second specification.None of the needles remained exposed.A trend has been identified for the reported failure and further actions have been initiated to investigate this type of incident and identify the root cause.The appropriate 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.

• 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: 23408542
• Report Number: 1710034-2025-01679
• Device Sequence Number: 15722454
• Product Code: FOZ
• UDI-Device Identifier: 00382903814336
• UDI-Public: (01)00382903814336(11)241104(17)271031(10)4305273
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: 381433
• Device Lot Number: 4305273
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown