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

Catalog Number	381023
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
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
It was reported that foreign matter was noted on the catheter.Cap removed to canulate pt.Small foreign body/debris noted on tip of the canular.Needle retracted and debris remain stuck to the cannula.Did not go into patient.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation summary: root cause couldn't be determined due to unavailability of sample information.A complaint history check was performed, and this is the 1st related complaint reported with the defect/condition of foreign matter with lot 5073713 regarding item 381023.Device history was reviewed.No related quality issues or process deviations were found during the manufacture of the subassembly lot and packaging line.A review of the applicable risk document indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.

• 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: 25016623
• Report Number: 1710034-2026-00473
• Device Sequence Number: 15829101
• Product Code: FOZ
• UDI-Device Identifier: 00382903810239
• UDI-Public: (01)00382903810239(10)5073713
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K251654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2026

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: 381023
• Device Lot Number: 5073713
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Supplement Date Received by Manufacturer: 05/19/2026; 07/02/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 05/20/2026; 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown