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

Catalog Number	381912
Medical Device Problem Codes	Material Frayed (1262); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that insyte autoguard winged leaked.The nurse attempted a peripherally inserted iv placement in the patient's left hand.The iv site was leaking, with the needle still in the catheter.As the nurse pulled the iv out, it was that the tip of the catheter was frayed.No infiltration or extravasation was noted.Additional information 5/7/2026: any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No adverse or serious injury to the patient.Can you please provide an exact date of event? (b)(6) 2026.
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
Correction: upon further review, it was determined that there was an additional failure that required capture.While it was reported in the tab b narrative, it had not been captured in the annex a coding.That has been corrected.Device evaluation: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a root cause for the reported incident could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the data collected for identification of emerging trends.
Additional Manufacturer Narrative
Correction: d.4.Udi.Additional investigation information: a review of the applicable risk documents indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.
Event or Problem Description
No additional 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: 25188544
• Report Number: 1710034-2026-00521
• Device Sequence Number: 10702771
• Product Code: FOZ
• UDI-Device Identifier: 00382903819126
• UDI-Public: (01)00382903819126
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K251654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2026

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: 381912
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Supplement Date Received by Manufacturer: Not provided; 05/21/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 05/21/2026; 05/22/2026
• 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 Age: 3 YR
• Patient Sex: Male
• Patient Weight: 39 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American