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

Catalog Number	381033
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
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It was reported that the needle did not retract.When the metal guide wire was withdrawn after the catheter was inserted, it did not remain in the chamber.It was reported that when the metal guide wire was released after the catheter was inserted, it did not retract into the chamber, meaning it had to be removed completely from the cannula, with a risk of accidental puncture when did the incident occur? during use.
Event or Problem Description
No additional information.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation summary: the reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.A complaint history check was performed, and this is the 1st related complaint reported with the defect/condition of needle retraction failure with lot 5164211 regarding item #381033.Dhr number 5164211 has been 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 documents 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: 24723942
• Report Number: 1710034-2026-00343
• Device Sequence Number: 21367216
• Product Code: FOZ
• UDI-Device Identifier: 00382903810338
• UDI-Public: (01)00382903810338
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K251654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2026

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: 381033
• Device Lot Number: 5164211
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Supplement Date Received by Manufacturer: 04/17/2026; 04/13/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/17/2026; 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown