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	03/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a customer that the catheter was observed to shred or tear.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.H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
The complaint of a damaged catheter was confirmed.However, the root cause could not be determined from the three photographs that were provided for investigation.The photos showed what two 24g insyte autoguard iv catheters.What appeared to be blood residue was observed on one iv catheter and the tip may have been damaged.The other catheter appeared to be breached near the midpoint of the catheter tubing.The image quality made it difficult to observe the features of the reported damage.The tubing may have been punctured with the needle.There were no distinguishing features which could aid in identification of a specific root cause.As the photographs support the complainant¿s description of the reported event, the complaint was confirmed.Without the physical samples, the characteristics of the reported damage and root cause of the event could not be determined.A review of the inspection records and quality and manufacturing controls for the implicated lot indicated no related issues with the manufacturing process.Manufacturing controls are in place to mitigate the occurrence of this type of failure.The complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Complaints received about this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the data collected for identification of emerging trends.
Event or Problem Description
No new information.

• 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: 24835159
• Report Number: 1710034-2026-00393
• Device Sequence Number: 9168680
• Product Code: FOZ
• UDI-Device Identifier: 00382903815111
• UDI-Public: (01)00382903815111(10)5255650
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2026

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: 5255650
• 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: 03/31/2026
• Supplement Date Received by Manufacturer: 04/28/2026; 06/17/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 04/28/2026; 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown