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

Catalog Number	382534
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
V therapy staff rn started an iv on a patient using a 20g 1.16in iv and the needle's safety mechanism, the button to retract the needle, was jammed.When trying to physically remove the needle from the hub after insertion, i was then met with slight resistance.After removal from the catheter, the safety still didn't activate to retract the needle into the center of the iv.Additional information received on 09jan2026 1.Can you please provide an exact date of event in mm-dd-yyyy format? 12/22/2025.2.What was the impact to the patient? iv start was ok, no pt issues.3.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.None.
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
No additional information.
Additional Manufacturer Narrative
Investigation results: a device history record review was completed by our quality engineer team for provided material number 382534 and lot number 5219747.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported issue, and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect similar issues during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.

• 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: 24056393
• Report Number: 1710034-2025-02043
• Device Sequence Number: 13128070
• Product Code: FOZ
• UDI-Device Identifier: 00382903825349
• UDI-Public: (01)00382903825349(17)280731(10)5219747
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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: 382534
• Device Lot Number: 5219747
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown