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

Catalog Number	381511
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	05/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a customer that the catheter was observed to shred or tear at the insertion site during the procedure.Was lot # 6016974 also affected? yes is a new complaint record needed for the sample lot # 6016974 received? this was included on our end, however if you do not have a complaint on your end then yes.It will be the same information and same concerns as the previous.Information from previous: it was reported by a customer that the catheter was observed to shred or tear.These insights are what we use in the nicu to start ivs.Unfortunately, we have had a couple now that split when you try to insert which causes the vein to blow.Additional information received on 31mar2026: on (b)(6) 2026, two additional insight devices were used¿one by an rn and one by an nnp.In both cases, the catheter was observed to shred or tear at the insertion site during the procedure.Please specify the number of patients involved and confirm whether both needle splits occurred with a single patient? two separate patients involved, separate dates and times with different staff involved.Describe any patient¿s harm, injury, complication, or negative outcome that occurred because of the event.Patients required multiple sticks as tear in catheter caused vein to rupture.
Additional Manufacturer Narrative
G.4.K201075; k251654 b3.The date received by manufacturer has been used for this field.H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

• Brand Name: INSYTE-N 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: 25448126
• Report Number: 1710034-2026-00637
• Device Sequence Number: 13165281
• Product Code: FOZ
• UDI-Device Identifier: 00382903815111
• UDI-Public: (01)00382903815111(11)260211(17)281231(10)6016974
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2026

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: 381511
• Device Lot Number: 6016974
• 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: 05/20/2026
• Supplement Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown